Article 49 
1. The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious adverse reactions, and adverse human reactions to a veterinary medicinal product authorised in accordance with the provisions of this Regulation occurring within the Community which a health-care professional brings to his attention are recorded and reported promptly to the Member States in the territory of which the incident occurred no later than 15 days following receipt of the information. The holder of the marketing authorisation shall record any other suspected serious adverse reactions and human adverse reactions occurring within the Community, in accordance with the guidelines referred to in Article 51, of which he may reasonably be expected to be aware, and promptly notify Member States in the territory of which the incident occurred and the Agency, and no later than 15 days following receipt of the information. 2. The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to the Member States and the Agency, and no later than 15 days following receipt of the information. The Commission shall adopt provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Community or in a third country. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a). Save in exceptional circumstances, these reactions shall be transmitted electronically in the form of a report and in accordance with the guide referred to in Article 51. 3. The holder of the marketing authorisation for a veterinary medicinal product shall maintain detailed records of all suspected adverse reactions occurring within or outside the Community which are reported to him. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation by the Community, these records shall be submitted, in the form of a periodic safety update report, to the Agency and Member States immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the Community market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. These reports shall be accompanied by a scientific evaluation, particularly of the risk-benefit balance of the medicinal product. 4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the procedure referred to in Article 87(2a). 5. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 49 ):
1. The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious adverse reactions, and adverse human reactions to a veterinary medicinal product authorised in accordance with the provisions of this Regulation occurring within the Union which a health-care professional brings to his attention are recorded and reported promptly to the Member States in the territory of which the incident occurred no later than 15 days following receipt of the information. The holder of the marketing authorisation shall record any other suspected serious adverse reactions and human adverse reactions occurring within the Union , in accordance with the guidelines referred to in Article 51, of which he may reasonably be expected to be aware, and promptly notify Member States in the territory of which the incident occurred and the Agency, and no later than 15 days following receipt of the information. 2. The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to the Member States and the Agency, and no later than 15 days following receipt of the information. The Commission shall adopt provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Union or in a third country. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a). Save in exceptional circumstances, these reactions shall be transmitted electronically in the form of a report and in accordance with the guide referred to in Article 51. 3. The holder of the marketing authorisation for a veterinary medicinal product shall maintain detailed records of all suspected adverse reactions occurring within or outside the Union which are reported to him. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation by the Union , these records shall be submitted, in the form of a periodic safety update report, to the Agency and Member States immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the Union market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. These reports shall be accompanied by a scientific evaluation, particularly of the risk-benefit balance of the medicinal product. 4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the procedure referred to in Article 87(2a). 5. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties.
Article 50 
Each Member State shall ensure that all suspected serious adverse reactions, and adverse human reactions, occurring within its territory to a veterinary medicinal product authorised in accordance with the provisions of this Regulation which are brought to its attention are recorded and reported promptly to the Agency and the holder of the marketing authorisation for the veterinary medicinal product, and no later than 15 days following receipt of the information. The Agency shall forward the information to the national pharmacovigilance systems set up in accordance with Article 73 of Directive 2001/82/EC.
Article 51 
The Commission, in consultation with the Agency, Member States and interested parties, shall draw up a guide on the collection, verification and presentation of adverse-reaction reports. This guide shall contain, in particular, for the benefit of health-care professionals, recommendations concerning the communication of information on adverse reactions. In accordance with this guide, holders of marketing authorisations shall use the medical terminology accepted at international level for the transmission of adverse-reaction reports. The Agency, in consultation with the Member States and the Commission, shall set up a data-processing network for the rapid transmission of data between the competent Community authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data regarding veterinary medicinal products authorised in accordance with Article 5 of Directive 2001/82/EC. For a period of five years following the initial placing on the market in the Community, the Agency may request that the marketing authorisation holder arrange for specific pharmacovigilance data to be collected from targeted groups of animals. The Agency shall state the reasons for the request. The marketing authorisation holder shall collate and assess the data collected and submit it to the Agency for evaluation.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 51 ):
The Commission, in consultation with the Agency, Member States and interested parties, shall draw up a guide on the collection, verification and presentation of adverse-reaction reports. This guide shall contain, in particular, for the benefit of health-care professionals, recommendations concerning the communication of information on adverse reactions. In accordance with this guide, holders of marketing authorisations shall use the medical terminology accepted at international level for the transmission of adverse-reaction reports. The Agency, in consultation with the Member States and the Commission, shall set up a data-processing network for the rapid transmission of data between the competent Union authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data regarding veterinary medicinal products authorised in accordance with Article 5 of Directive 2001/82/EC. For a period of five years following the initial placing on the market in the Union, the Agency may request that the marketing authorisation holder arrange for specific pharmacovigilance data to be collected from targeted groups of animals. The Agency shall state the reasons for the request. The marketing authorisation holder shall collate and assess the data collected and submit it to the Agency for evaluation.
Article 52 
The Agency shall cooperate with international organisations concerned with veterinary pharmacovigilance.
Article 53 
The Agency and the Member States' competent authorities shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of routes of authorisation, including the use of collaborative approaches, to maximise use of resources available within the Community.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 53 ):
The Agency and the Member States' competent authorities shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of routes of authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union .
Article 54 
The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).
Article 55 
A European Medicines Agency is hereby established. The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
Article 56 
1. The Agency shall comprise: (a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; (b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use; (c) the Committee on Orphan Medicinal Products; (d) the Committee on Herbal Medicinal Products; (da) the Committee for Advanced Therapies; (e) the Paediatric Committee; (f) a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them; (g) an Executive Director, who shall exercise the responsibilities set out in Article 64; (h) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67. 2. The committees referred to in paragraph paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30. When establishing working parties and scientific advisory groups, the committees shall in their rules of procedures referred to in Article 61(8) provide for: (a) the appointment of members of these working parties and scientific advisory groups on the basis of the lists of experts referred to in the second subparagraph of Article 62(2); and (b) consultation of these working parties and scientific advisory groups. 3. The Executive Director, in close consultation with the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in Article 57(1)(n), particularly regarding the development of new therapies. Each committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings. 4. The Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 56 ):
1. The Agency shall comprise: (a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; (aa) the Pharmacovigilance Risk Assessment Committee, which shall be responsible for providing recommendations to the Committee for Medicinal Products for Human Use and the coordination group on any question relating to pharmacovigilance activities in respect of medicinal products for human use and on risk management systems and it shall be responsible for monitoring the effectiveness of those risk management systems; (b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use; (c) the Committee on Orphan Medicinal Products; (d) the Committee on Herbal Medicinal Products; (da) the Committee for Advanced Therapies; (e) the Paediatric Committee; (f) a Secretariat, which shall provide technical, scientific and administrative support for the Committees and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group and ensure appropriate coordination between it and the Committees; (g) an Executive Director, who shall exercise the responsibilities set out in Article 64; (h) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67. 2. The committees referred to in paragraph paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30. When establishing working parties and scientific advisory groups, the committees shall in their rules of procedures referred to in Article 61(8) provide for: (a) the appointment of members of these working parties and scientific advisory groups on the basis of the lists of experts referred to in the second subparagraph of Article 62(2); and (b) consultation of these working parties and scientific advisory groups. 3. The Executive Director, in close consultation with the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in Article 57(1)(n), particularly regarding the development of new therapies. Each committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings. 4. The Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.
Article 57 
1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products. To this end, the Agency, acting particularly through its committees, shall undertake the following tasks: (a) coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorisation procedures; (b) transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; (c) coordination of the supervision, under practical conditions of use, of medicinal products which have been authorised within the Community and the provision of advice on the measures necessary to ensure the safe and effective use of these products, in particular by evaluation, coordination of the implementation of pharmacovigilance obligations and the monitoring of such implementation; (d) ensuring the dissemination of information on adverse reactions to medicinal products authorised in the Community, by means of a database permanently accessible to all Member States; health-care professionals, marketing authorisation holders and the public shall have appropriate levels of access to these databases, with personal data protection being guaranteed; (e) assisting Member States with the rapid communication of information concerning pharmacovigilance to health-care professionals. (f) distributing appropriate pharmacovigilance information to the general public; (g) advising on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin ( 19 ); (h) providing scientific advice on the use of antibiotics in food-producing animals in order to minimise the occurrence of bacterial resistance in the Community; this advice shall be updated when needed; (i) coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and the verification of compliance with pharmacovigilance obligations; (j) upon request, providing technical and scientific support in order to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation; (k) recording the status of marketing authorisations for medicinal products granted in accordance with Community procedures; (l) creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner; (m) assisting the Community and Member States in the provision of information to health-care professionals and the general public about medicinal products evaluated by the Agency; (n) advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products; (o) checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation; (p) drawing up, at the Commission's request, any other scientific opinion concerning the evaluation of medicinal products or the starting materials used in the manufacture of medicinal products; (q) with a view to the protection of public health, compilation of scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products available to prevent, or to treat, the effects of such agents; (r) coordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose; (s) forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures; (t) taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use ( 20 ). 2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Community. Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 57 ):
1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products. To this end, the Agency, acting particularly through its committees, shall undertake the following tasks: (a) coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorisation procedures; (b) transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; (c) coordinating the monitoring of medicinal products for human use which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of these medicinal products for human use, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation; (d) ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products for human use authorised in the Union by means of a database permanently accessible to all Member States; (e) assisting Member States with the rapid communication of information on pharmacovigilance concerns to healthcare professionals and coordinating the safety announcements of the national competent authorities; (f) distributing appropriate information on pharmacovigilance concerns to the general public, in particular by setting up and maintaining a European medicines web-portal; (g) advising on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin ( 19 ); (h) providing scientific advice on the use of antibiotics in food-producing animals in order to minimise the occurrence of bacterial resistance in the Community; this advice shall be updated when needed; (i) coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and the verification of compliance with pharmacovigilance obligations; (j) upon request, providing technical and scientific support in order to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation; (k) recording the status of marketing authorisations for medicinal products granted in accordance with Community procedures; (l) creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner; (m) assisting the Community and Member States in the provision of information to health-care professionals and the general public about medicinal products evaluated by the Agency; (n) advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products; (o) checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation; (p) drawing up, at the Commission's request, any other scientific opinion concerning the evaluation of medicinal products or the starting materials used in the manufacture of medicinal products; (q) with a view to the protection of public health, compilation of scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products available to prevent, or to treat, the effects of such agents; (r) coordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose; (s) forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures; (t) taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use ( 20 ). 2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Community. For the purposes of the database, the Agency shall set up and maintain a list of all medicinal products for human use authorised in the Union. To this effect the following measures shall be taken: (a) the Agency shall, by 2 July 2011 at the latest, make public a format for the electronic submission of information on medicinal products for human use; (b) marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised or registered in the Union, using the format referred to in point (a); (c) from the date set out in point (b), marketing authorisation holders shall inform the Agency of any new or varied marketing authorisations granted in the Union, using the format referred to in point (a). Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.
Article 58 
1. The Agency may give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply. 2. The said Committee shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 58 ):
1. The Agency may give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Union . For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply. 2. The said Committee shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice.
Article 59 
1. The Agency shall take care to ensure early identification of potential sources of conflict between its scientific opinions and those of other bodies established under Community law carrying out a similar task in relation to issues of common concern. 2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific information is shared and to identify the scientific points which potentially conflict. 3. Where there is a fundamental conflict over scientific points and the body concerned is a Community agency or a scientific committee, the Agency and the body concerned shall work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific points of conflict. This document shall be published immediately after its adoption. 4. Save as otherwise provided in this Regulation, in Directive 2001/83/EC or in Directive 2001/82/EC, where there is a fundamental conflict over scientific points and the body concerned is a body in a Member State, the Agency and the national body concerned shall work together either to resolve the conflict or to prepare a joint document clarifying the scientific points of conflict. This document shall be published immediately after its adoption.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 59 ):
1. The Agency shall take care to ensure early identification of potential sources of conflict between its scientific opinions and those of other bodies established under Union law carrying out a similar task in relation to issues of common concern. 2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific information is shared and to identify the scientific points which potentially conflict. 3. Where there is a fundamental conflict over scientific points and the body concerned is a Union agency or a scientific committee, the Agency and the body concerned shall work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific points of conflict. This document shall be published immediately after its adoption. 4. Save as otherwise provided in this Regulation, in Directive 2001/83/EC or in Directive 2001/82/EC, where there is a fundamental conflict over scientific points and the body concerned is a body in a Member State, the Agency and the national body concerned shall work together either to resolve the conflict or to prepare a joint document clarifying the scientific points of conflict. This document shall be published immediately after its adoption.
Article 60 
At the request of the Commission, the Agency shall, in respect of authorised medicinal products, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product provides.
Article 61 
1. Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use and one member and one alternate to the Committee for Medicinal Products for Veterinary Use. The alternates shall represent and vote for the members in their absence and may act as rapporteurs in accordance with Article 62. Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human and veterinary use as appropriate and shall represent the competent national authorities. 2. The committees may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. With a view to the co-opting of such members, the committees shall identify the specific complementary scientific competence of the additional member(s). Co-opted members shall be chosen among experts nominated by Member States or the Agency. 3. The members of each Committee may be accompanied by experts in specific scientific or technical fields. 4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the committees, working parties and scientific advisory groups and all other meetings convened by the Agency or its committees. 5. In addition to their task of providing objective scientific opinions to the Community and Member States on the questions which are referred to them, the members of each committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation. 6. Members of the committees and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies. Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated committee members and experts. Member States shall refrain from giving committee members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency. 7. When preparing the opinion, each committee shall use its best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based. 8. Each committee shall establish its own rules of procedure. These rules shall, in particular, lay down: (a) procedures for appointing and replacing the Chairman; (b) procedures relating to working parties and scientific advisory groups; and (c) a procedure for the urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance. They shall enter into force after receiving a favourable opinion from the Commission and the Management Board.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 61 ):
1. Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use and one member and one alternate to the Committee for Medicinal Products for Veterinary Use. The alternates shall represent and vote for the members in their absence and may act as rapporteurs in accordance with Article 62. Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human and veterinary use as appropriate and shall represent the competent national authorities. 2. The committees may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. With a view to the co-opting of such members, the committees shall identify the specific complementary scientific competence of the additional member(s). Co-opted members shall be chosen among experts nominated by Member States or the Agency. 3. The members of each Committee may be accompanied by experts in specific scientific or technical fields. 4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the committees, working parties and scientific advisory groups and all other meetings convened by the Agency or its committees. 5. In addition to their task of providing objective scientific opinions to the Union and Member States on the questions which are referred to them, the members of each committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation. 6. Members of the committees and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies. Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated committee members and experts. Member States shall refrain from giving committee members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency. 7. When preparing the opinion, each committee shall use its best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based. 8. Each committee shall establish its own rules of procedure. These rules shall, in particular, lay down: (a) procedures for appointing and replacing the Chairman; (b) procedures relating to working parties and scientific advisory groups; and (c) a procedure for the urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance. They shall enter into force after receiving a favourable opinion from the Commission and the Management Board.
Article 62 
1. Where, in accordance with the provisions of this Regulation, the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use is required to evaluate a medicinal product, it shall appoint one of its members to act as rapporteur for the coordination of the evaluation. The Committee concerned may appoint a second member to act as co-rapporteur. When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) and Article 31(3) are met. The substance of the opinion shall be included in the assessment report published pursuant to Article 13(3) and Article 38(3). If there is a request for re-examination of one of its opinions, the Committee concerned shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the initial opinion. The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the initial opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination. 2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use, together with an indication of their qualifications and specific areas of expertise. The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed directly by the Agency. The list shall be updated. 3. The provision of services by rapporteurs or experts shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and his employer. The person concerned, or his employer, shall be remunerated in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. 4. The performance of scientific services for which there are several potential providers may result in a call for an expression of interest, if the scientific and technical context allows, and if it is compatible with the tasks of the Agency, in particular to ensure a high level of public health protection. The Management Board shall adopt the appropriate procedures on a proposal from the Executive Director. 5. The Agency or any of the committees referred to in Article 56(1) may use the services of experts for the discharge of other specific tasks for which they are responsible.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 62 ):
1. Where, in accordance with this Regulation, any of the Committees referred to in Article 56(1) is required to evaluate a medicinal product for human use, it shall appoint one of its members to act as rapporteur, taking into account existing expertise in the Member State. The Committee concerned may appoint a second member to act as co-rapporteur. A rapporteur appointed for this purpose by the Pharmacovigilance Risk Assessment Committee shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal product for human use concerned. When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) and Article 31(3) are met. The substance of the opinion shall be included in the assessment report published pursuant to Article 13(3) and Article 38(3). If there is a request for re-examination of one of its opinions where this possibility is provided for in Union law, the Committee concerned shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the initial opinion. The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the initial opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination. 2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise. The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed directly by the Agency. The list shall be updated. 3. The provision of services by rapporteurs or experts shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and his employer. The person concerned, or his employer, shall be remunerated in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. The first and second subparagraphs shall also apply to the work of rapporteurs in the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC. 4. The performance of scientific services for which there are several potential providers may result in a call for an expression of interest, if the scientific and technical context allows, and if it is compatible with the tasks of the Agency, in particular to ensure a high level of public health protection. The Management Board shall adopt the appropriate procedures on a proposal from the Executive Director. 5. The Agency or any of the committees referred to in Article 56(1) may use the services of experts for the discharge of other specific tasks for which they are responsible.
Article 63 
1. The membership of the committees referred to in Article 56(1) shall be made public. When each appointment is published, the professional qualifications of each member shall be specified. 2. Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices. The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts. Members of the Management Board, members of the committees, rapporteurs and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence with respect to the items on the agenda. These declarations shall be made available to the public.
Article 64 
1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post. 2. The Executive Director shall be the legal representative of the Agency. He shall be responsible: (a) for the day-to-day administration of the Agency; (b) for managing all the Agency resources necessary for conducting the activities of the committees referred to in Article 56(1), including making available appropriate scientific and technical support; (c) for ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with; (d) for ensuring appropriate coordination between the committees referred to in Article 56(1); (e) for the preparation of the draft statement of estimates of the Agency's revenue and expenditure, and execution of its budget; (f) for all staff matters; (g) for providing the secretariat for the Management Board. 3. Each year the Executive Director shall submit a draft report covering the activities of the Agency in the previous year and a draft work programme for the coming year to the Management Board for approval, making a distinction between the Agency's activities concerning medicinal products for human use, those concerning herbal medicinal products and those concerning veterinary medicinal products. The draft report covering the activities of the Agency in the previous year shall include information about the number of applications evaluated within the Agency, the time taken for completion of the evaluation and the medicinal products authorised, rejected or withdrawn.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 64 ):
1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post. 2. The Executive Director shall be the legal representative of the Agency. He shall be responsible: (a) for the day-to-day administration of the Agency; (b) for managing all the Agency resources necessary for conducting the activities of the Committees referred to in Article 56(1), including making available appropriate scientific and technical support to those Committees, and for making available appropriate technical support to the coordination group; (c) for ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with; (d) for ensuring appropriate coordination between the Committees referred to in Article 56(1) and, where necessary, between the Committees and the coordination group; (e) for the preparation of the draft statement of estimates of the Agency's revenue and expenditure, and execution of its budget; (f) for all staff matters; (g) for providing the secretariat for the Management Board. 3. Each year the Executive Director shall submit a draft report covering the activities of the Agency in the previous year and a draft work programme for the coming year to the Management Board for approval, making a distinction between the Agency's activities concerning medicinal products for human use, those concerning herbal medicinal products and those concerning veterinary medicinal products. The draft report covering the activities of the Agency in the previous year shall include information about the number of applications evaluated within the Agency, the time taken for completion of the evaluation and the medicinal products authorised, rejected or withdrawn.
Article 65 
1. The Management Board shall consist of one representative of each Member State, two representatives of the Commission and two representatives of the European Parliament. In addition, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint the Management Board. The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union. 2. The members of the Management Board shall be appointed on the basis of their relevant expertise in management and, if appropriate, experience in the field of medicinal products for human or veterinary use. 3. Each Member State and the Commission shall appoint their members of the Management Board as well as an alternate who will replace the member in his absence and vote on his behalf. 4. The term of office of the representatives shall be three years. The term of office may be renewed. 5. The Management Board shall elect its Chairman from among its members. The term of office of the Chairman shall be three years and shall expire when he ceases to be a member of the Management Board. The term of office may be renewed once. 6. Decisions of the Management Board shall be adopted by a majority of two-thirds of its members. 7. The Management Board shall adopt its rules of procedure. 8. The Management Board may invite the chairmen of the scientific committees to attend its meetings, but they shall not have the right to vote. 9. The Management Board shall approve the annual work programme of the Agency programme and forward it to the European Parliament, the Council, the Commission and the Member States. 10. The Management Board shall adopt the annual report on the Agency's activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States.
Article 66 
The Management Board shall: (a) adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (Article 61); (b) adopt procedures for the performance of scientific services (Article 62); (c) appoint the Executive Director (Article 64); (d) adopt the annual work programme and forward it to the European Parliament, the Council, the Commission and the Member States (Article 65); (e) approve the annual report on the Agency's activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States (Article 65); (f) adopt the budget of the Agency (Article 67); (g) adopt the internal financial provisions (Article 67); (h) adopt provisions implementing the Staff Regulations (Article 75); (i) develop contacts with stakeholders and stipulate the conditions applicable (Article 78); (j) adopt provisions for providing assistance to pharmaceutical companies (Article 79); (k) adopt rules to ensure the availability to the public of information concerning the authorisation or supervision of medicinal products (Article 80).
Article 67 
1. Estimates of all the revenue and expenditure of the Agency shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the budget of the Agency. 2. The revenue and expenditure shown in the budget shall be in balance. 3. The Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency. The European Parliament and the Council (hereinafter referred to as ‘the budgetary authority’) shall re-examine, when necessary, the level of the Community contribution on the basis of an evaluation of needs and taking account of the level of fees. 4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall receive adequate public funding commensurate with the tasks conferred. 5. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure costs, and operating expenses as well as expenses resulting from contracts entered into with third parties. 6. Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce an estimate of revenue and expenditure for the Agency for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest. 7. The estimate shall be forwarded by the Commission to the budgetary authority together with the preliminary draft general budget of the European Union. 8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty. 9. The budgetary authority shall authorise the appropriations for the subsidy to the Agency. The budgetary authority shall adopt the establishment plan for the Agency. 10. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly. 11. Any modification of the establishment plan and of the budget shall be the subject of an amending budget, which is forwarded for the purposes of information to the budgetary authority. 12. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 67 ):
1. Estimates of all the revenue and expenditure of the Agency shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the budget of the Agency. 2. The revenue and expenditure shown in the budget shall be in balance. 3. The Agency’s revenue shall consist of a contribution from the Union and fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC. The European Parliament and the Council (hereinafter referred to as ‘the budgetary authority’) shall re-examine, when necessary, the level of the Community contribution on the basis of an evaluation of needs and taking account of the level of fees. 4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. This shall not preclude the Agency from charging fees to marketing authorisation holders for performing these activities by the Agency on the condition that its independence is strictly guaranteed. 5. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure costs, and operating expenses as well as expenses resulting from contracts entered into with third parties. 6. Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce an estimate of revenue and expenditure for the Agency for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest. 7. The estimate shall be forwarded by the Commission to the budgetary authority together with the preliminary draft general budget of the European Union. 8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty. 9. The budgetary authority shall authorise the appropriations for the subsidy to the Agency. The budgetary authority shall adopt the establishment plan for the Agency. 10. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly. 11. Any modification of the establishment plan and of the budget shall be the subject of an amending budget, which is forwarded for the purposes of information to the budgetary authority. 12. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 68 
1. The Executive Director shall implement the budget of the Agency. 2. By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation applicable to the general budget of the European Communities ( 21 ) (hereinafter referred to as the ‘general Financial Regulation’). 3. By 31 March at the latest following each financial year, the Commission's accounting officer shall submit the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council. 4. On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of the general Financial Regulation, the Executive Director shall draw up the Agency's final accounts under his own responsibility and submit them to the Management Board for an opinion. 5. The Management Board of the Agency shall deliver an opinion on the Agency's final accounts. 6. The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion. 7. The final accounts shall be published. 8. The Agency's Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board. 9. The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation. 10. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N. 11. The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities ( 22 ), unless specifically required for the Agency's operation and with the Commission's prior consent.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 68 ):
1. The Executive Director shall implement the budget of the Agency in accordance with Regulation (EU) 2018/1046 of the European Parliament and of the Council ( 6 ) (‘the Financial Regulation’). 2. By 1 March of financial year n+1, the Agency’s accounting officer shall send the provisional accounts for year n to the Commission’s accounting officer and to the Court of Auditors. 3. By 31 March of financial year n+1, the Executive Director shall send the report on the budgetary and financial management for year n to the European Parliament, to the Council, to the Commission and to the Court of Auditors. 4. By 31 March of financial year n+1, the Commission’s accounting officer shall send the Agency’s provisional accounts for year n, consolidated with the Commission’s provisional accounts, to the Court of Auditors. On receipt of the Court of Auditors’ observations on the Agency’s provisional accounts pursuant to Article 246 of the Financial Regulation, the Agency’s accounting officer shall draw up the Agency’s final accounts and the Executive Director shall submit them to the Management Board for an opinion. 5. The Management Board shall deliver an opinion on the Agency’s final accounts for year n. 6. The Agency’s accounting officer shall, by 1 July of financial year n+1, send the final accounts, together with the Management Board’s opinion, to the European Parliament, to the Council, to the Court of Auditors and to the Commission’s accounting officer. 7. The final accounts for year n shall be published in the Official Journal of the European Union by 15 November of financial year n+1. 8. The Executive Director shall send to the Court of Auditors a reply to its observations by 30 September of financial year n+1. The Executive Director shall also send that reply to the Management Board. 9. The Executive Director shall submit to the European Parliament, at the latter’s request, any information required for the smooth application of the discharge procedure for the financial year concerned, as laid down in Article 261(3) of the Financial Regulation. 10. The European Parliament, upon a recommendation from the Council, shall, before 15 May of financial year n+2, give a discharge to the Executive Director in respect of the implementation of the budget for year n. 11. The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They shall not depart from Commission Delegated Regulation (EU) No 1271/2013 ( 7 ) unless specifically required for the Agency’s operation and with the Commission’s prior consent.
Article 69 
1. In order to combat fraud, corruption and other unlawful activities the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) ( 23 ) shall apply without restriction. 2. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the European Anti-Fraud Office (OLAF) and shall issue, without delay, the appropriate provisions applicable to all the employees of the Agency.
Article 70 
1. The structure and the level of the fees referred to in Article 67(3) shall be established by the Council acting under the conditions provided for by the Treaty on a proposal from the Commission, once the Commission has consulted organisations representing the interests of the pharmaceutical industry at Community level. 2. However, the Commission shall adopt provisions establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 70 ):
1. The structure and the level of the fees referred to in Article 67(3) shall be established by the Council acting under the conditions provided for by the Treaty on a proposal from the Commission, once the Commission has consulted organisations representing the interests of the pharmaceutical industry at Union level. 2. However, the Commission shall adopt provisions establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).
Article 71 
The Agency shall have legal personality. In all Member States it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may in particular acquire or dispose of movable and immovable property and may be a party to legal proceedings.
Article 72 
1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice of the European Communities shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency. 2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating to compensation for any such damage. 3. The personal liability of its servants towards the Agency shall be governed by the relevant rules applying to the staff of the Agency.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 72 ):
1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice of the European Union shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency. 2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating to compensation for any such damage. 3. The personal liability of its servants towards the Agency shall be governed by the relevant rules applying to the staff of the Agency.
Article 73 
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents ( 24 ) shall apply to documents held by the Agency. The Agency shall set up a register pursuant to Article 2(4) of Regulation (EC) No 1049/2001 to make available all documents that are publicly accessible pursuant to this Regulation. The Management Board shall adopt the arrangements for implementing Regulation (EC) No 1049/2001 within six months of entry into force of this Regulation. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to the lodging of a complaint with the Ombudsman or form the subject of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.
Article 73a 
Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 73a ):
Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Union under the conditions laid down in Article 230 of the Treaty.
Article 74 
The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 74 ):
The Protocol on the Privileges and Immunities of the European Union shall apply to the Agency.
Article 75 
The staff of the Agency shall be subject to the rules and regulations applicable to officials and other staff of the European Communities. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority. The Management Board, in agreement with the Commission, shall adopt the necessary implementing provisions.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 75 ):
The staff of the Agency shall be subject to the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the European Union. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority. The Management Board, in agreement with the Commission, shall adopt the necessary implementing provisions.
Article 76 
Members of the Management Board, members of the committees referred to in Article 56(1), and experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.
Article 77 
The Commission may, in agreement with the Management Board and the relevant committee, invite representatives of international organisations with an interest in the harmonisation of regulations applicable to medicinal products to participate as observers in the work of the Agency. The conditions for participation shall be determined beforehand by the Commission.
Article 78 
1. The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the health professions. These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission. 2. The committees referred to in Article 56(1) and any working parties and scientific advisory groups established in accordance with that Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products, in particular patient organisations and health-care professionals' associations. Rapporteurs appointed by these committees may, on an advisory basis, establish contacts with representatives of patient organisations and health-care professionals' associations relevant to the indication of the medicinal product concerned.
Article 79 
The Management Board shall, in the case of veterinary medicinal products which have limited markets, or in the case of veterinary medicinal products intended for diseases with a regional distribution, adopt the necessary measures to provide assistance to companies at the time of submission of their applications.
Article 80 
To ensure an appropriate level of transparency, the Management Board, on the basis of a proposal by the Executive Director and in agreement with the Commission, shall adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature. The internal rules and procedures of the Agency, its committees and its working groups shall be made available to the public at the Agency and on the Internet.
Article 81 
1. All decisions to grant, refuse, vary, suspend, withdraw or revoke a marketing authorisation which are taken in accordance with this Regulation shall state in detail the reasons on which they are based. Such decisions shall be notified to the party concerned. 2. An authorisation to place a medicinal product governed by this Regulation on the market shall not be granted, refused, varied, suspended, withdrawn or revoked except through the procedures and on the grounds set out in this Regulation.
Article 82 
1. Only one authorisation may be granted to an applicant for a specific medicinal product. However, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons. 2. As regards medicinal products for human use, Article 98(3) of Directive 2001/83/EC shall apply to medicinal products authorised under this Regulation. 3. Without prejudice to the unique, Community nature of the content of the documents referred to in Article 9(4)(a), (b), (c) and (d) and in Article 34(4)(a) to (e), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product covered by a single authorisation.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 82 ):
1. Only one authorisation may be granted to an applicant for a specific medicinal product. However, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons. 2. As regards medicinal products for human use, Article 98(3) of Directive 2001/83/EC shall apply to medicinal products authorised under this Regulation. 3. Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4) and in points (a) to (e) of Article 34(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.
Article 83 
1. By way of exemption from Article 6 of Directive 2001/83/EC Member States may make a medicinal product for human use belonging to the categories referred to in Article 3(1) and (2) of this Regulation available for compassionate use. 2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3(1) and (2) available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 of this Regulation or must be undergoing clinical trials. 3. When a Member State makes use of the possibility provided for in paragraph 1 it shall notify the Agency. 4. When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated on a regular basis. 5. Member States shall take account of any available opinions. 6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4, which shall be published on its website. Article 24(1) and Article 25 shall apply mutatis mutandis . 7. The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation. 8. Where a compassionate use programme has been set up, the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market. 9. This Article shall be without prejudice to Directive 2001/20/EC and to Article 5 of Directive 2001/83/EC.
Amendment rationale: CONTEXT OF THE PROPOSAL On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012. The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system. Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed. In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. 
Revised version (Article 83 ):
1. By way of exemption from Article 6 of Directive 2001/83/EC Member States may make a medicinal product for human use belonging to the categories referred to in Article 3(1) and (2) of this Regulation available for compassionate use. 2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3(1) and (2) available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 of this Regulation or must be undergoing clinical trials. 3. When a Member State makes use of the possibility provided for in paragraph 1 it shall notify the Agency. 4. When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated on a regular basis. 5. Member States shall take account of any available opinions. 6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4, which shall be published on its website. Article 28(1) and (2) shall apply mutatis mutandis . 7. The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation. 8. Where a compassionate use programme has been set up, the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market. 9. This Article shall be without prejudice to Directive 2001/20/EC and to Article 5 of Directive 2001/83/EC.
Article 84 
1. Without prejudice to the Protocol on the Privileges and Immunities of the European Communities, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the regulations adopted pursuant to it and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive. Member States shall inform the Commission of these provisions no later than 31 December 2004. They shall notify any subsequent alterations as soon as possible. 2. Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation. 3. At the Agency's request, the Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with the authorisations. The maximum amounts as well as the conditions and methods for collection of these penalties shall be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a). The Commission shall publish the names of the marketing authorisation holders involved and the amounts of and reasons for the financial penalties imposed.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The European Medicines Agency has been established by Regulation (EEC) No 2309/93, which has been replaced by Regulation (EC) No 726/2004 1 . In accordance with Article 1 of Decision of 29 October 1993 taken by common agreement between the representatives of the governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol 2 , the European Medicines Agency has its seat in London, United Kingdom. On 29 March 2017 the United Kingdom notified to the European Council its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union. On 20 November 2017, the 27 remaining Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency.
Revised version (Article 84 ):
1. Without prejudice to the Protocol on the Privileges and Immunities of the European Union , each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the regulations adopted pursuant to it and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive. Member States shall inform the Commission of these provisions no later than 31 December 2004. They shall notify any subsequent alterations as soon as possible. 2. Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
Article 85 
This Regulation shall not affect the competences vested in the European Food Safety Authority created by Regulation (EC) No 178/2002 ( 25 ).
Article 86 
At least every ten years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC and in Chapter 4 of Title III of Directive 2001/82/EC.
Article 87 
1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121 of Directive 2001/83/EC and by the Standing Committee on Veterinary Medicinal Products set up by Article 89 of Directive 2001/82/EC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
Article 88 
Regulation (EEC) No 2309/93/EC is hereby repealed. References to the repealed Regulation shall be construed as references to this Regulation.
Article 89 
The periods of protection provided for in Articles 14(11) and 39(10) shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date referred to in Article 90, second paragraph.
Article 90 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . By way of derogation from the first paragraph, Titles I, II, III and V shall apply from 20 November 2005 and point 3, fifth and sixth indent of the Annex shall apply from 20 May 2008. This Regulation shall be binding in its entirety and directly applicable in all Member States.