prop · H00340 · 2012-11-12 00:00:00 — (d)the modalities for the verification of the safety features referred to in point (o) of Article 54 by the manu facturers, wholesalers, pharmacists and persons auth orised or entitled to supply medicinal products to the public and by the competent authorities. Those modalities shall allow the verification of the auth enticity of each supplied pack of the medicinal products bearing the safety features referred to in point (o) of Article 54 and determine the extent of such verification. When establishing those modalities, the particular characteristics of the supply chains in Member States, and the need to ensure that the impact of verification measures on particular actors in the supply chains is proportionate, shall be taken into account; (e)provisions on the , management and accessibility of the repositories system in which information on the safety features, enabling the verifi cation of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained. The costs of the reposi tories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features. When adopting the measures referred to in paragraph 2, the Commission shall take due account of at least the following: (a)the protection of personal data as provided for in Union law; (b)the legitimate interests to protect information of a commercially confidential nature; (c)the ownership and confidentiality of the data generated by the use of the safety features; and (d)the cost-effectiveness of the measures. 4.The national competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification and may inform the Commission of medicinal products which they deem not to be at risk according to the criteria set out in point (b) of paragraph 2 of this Article. 5.Member States may, for the purposes of reim bursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement. Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article. Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any medicinal product. (13)in Article 57, the fourth indent of the first paragraph is replaced by the following: authenticity and identification in accordance with Article 54a(5). (14)the heading of title VII is replaced by the following: Wholesale distribution and brokering of medicinal products; (15)in Article 76, paragraph 3 is replaced by the following: distributor, not being the marketing authori sation holder, who imports a medicinal product from another notify the marketing authori sation holder and the competent authority in the to which the medicinal product will be imported of his intention to import that product. In the case of medicinal products which have not been granted an auth orisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that and to fees payable to the competent authority for examining the notification. 4.In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed. (16)Article 77 is amended as follows: (a)paragraph 1 is replaced by the following: Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid. (b)paragraphs 4 and 5 are replaced by the following: Member States shall enter the information relating to the authorisations referred to in paragraph 1of this Article in the Union database referred to in Article 111(6). At the request of the Commission or any , Member States shall provide all appropriate information concerning the individual authorisations which they have granted under paragraph 1 of this Article. 5.Checks on the persons authorised to engage in activity as a wholesaler in medicinal products, and the inspection of their premises, shall be carried out under the responsibility of the which granted the authorisation for premises located on its territory. L 174/82 (17)Article 80 is amended as follows: (a)the following point is inserted: (ca) they must verify that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts referred to in Article 54a(2);; (b)point (e) is replaced by the following: (e) they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or brokered at least the following information: name of the medicinal product, quantity received, supplied or brokered, name and address of the supplier or consignee, as appropriate, batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54;; (c)the following points are added: (h) they must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities; (i)they must immediately inform the competent authority and, where applicable, the marketing authorisation holder, of medicinal products they receive or are offered which they identify as falsified or suspect to be falsified. (d)the following paragraphs are added: For the purposes of point (b), where the medicinal product is obtained from another wholesale distributor, wholesale distribution authorisation holders must verify compliance with the principles and guidelines of good distribution practices by the supplying wholesale distributor. This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation. Where the medicinal product is obtained from the manufacturer or importer, wholesale distribution auth orisation holders must verify that the manufacturer or importer holds a manufacturing authorisation. Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holders must verify that the broker involved fulfils the requirements set out in this Directive. (18)in the first paragraph of Article 82, the following indent is added: batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54;; (19)the following Articles are inserted: In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of Article 80 shall not apply. Moreover, points (b) and (ca) of Article 80 shall not apply where a product is directly received from a third country but not imported. The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public. Persons brokering medicinal products shall ensure that the brokered medicinal products are covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a in accordance with this Directive. Persons brokering medicinal products shall have a permanent address and contact details in the Union, so as to ensure accurate identification, location, communi cation and supervision of their activities by competent authorities. The requirements set out in points (d) to (i) of Article 80 shall apply mutatis mutandis to the brokering of medicinal products. Persons may only broker medicinal products if they are registered with the competent authority of the of their permanent address referred to in paragraph 1. Those persons shall submit, at least, their name, corporate name and permanent address in order to register. They shall notify the competent authority of any changes thereof without unnecessary delay. Persons brokering medicinal products who had commenced their activity before 2 January 2013 shall register with the competent authority by 2 2013. The competent authority shall enter the information referred to in the first subparagraph in a register that shall be publicly accessible. The guidelines referred to in Article 84 shall include specific provisions for brokering. This Article shall be without prejudice to Article 111. Inspections referred to in Article 111 shall be carried out under the responsibility of the where the person brokering medicinal products is registered. L 174/83 If a person brokering medicinal products does not comply with the requirements set out in this Article, the competent authority may decide to remove that person from the register referred to in paragraph 2. The competent authority shall notify that person thereof. (20)the following Title is inserted before Title VIII: TITLE DISTANCE TO THE PUBLIC Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of information society services as defined in Directive 98/34/EC of Parliament and of 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on services (*) under the following conditions: (a)the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the in which that person is established; (b)the person referred to in point (a) has notified the in which that person is established of at least the following information: (i)name or corporate name and permanent address of the place of activity from where those medicinal products are supplied; (ii)the starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services; (iii)the address of the website used for that purpose and all relevant information necessary to identify that website; (iv)if applicable, the classification in accordance with Title VI of the medicinal products offered for sale at a distance to the public by means of information society services. Where appropriate, that information shall be updated; (c)the medicinal products comply with the national legis lation of the of destination in accordance with Article 6(1); (d)without prejudice to the information requirements set out in Directive 2000/31/EC of Parliament and of 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (**), the website offering the medicinal products contains at least: (i)the contact details of the competent authority or the authority notified pursuant to point (b); (ii)a hyperlink to the website referred to in paragraph 4 of the of ; (iii)the common logo referred to in paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of medicinal products. The common logo shall contain a hyperlink to the entry of the person in the list referred to in point (c) of paragraph 4. 2.Member States may impose conditions, justified on grounds of public health protection, for the retail supply on their territory of medicinal products for sale at a distance to the public by means of information society services. 3.A common logo shall be established that is recog nisable throughout the Union, while enabling the identifi cation of the where the person offering medicinal products for sale at a distance to the public is established. That logo shall be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with point (d) of paragraph 1. In order to harmonise the functioning of the common logo, the Commission shall adopt implementing acts regarding: (a) the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo; (b) the design of the common logo. Those implementing acts shall, where necessary, be amended to take account of technical and scientific progress. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2). Each set up a website providing at least the following: (a) information on the national legislation applicable to the offering of medicinal products for sale at a distance to the public by means of information society services, including information on the fact that there may be differences between Member States regarding classification of medicinal products and the conditions for their supply; (b)information on the purpose of the common logo; (c)the list of persons offering the medicinal products for sale at a distance to the public by means of information society services in accordance with paragraph 1 as well as their website addresses; (d)background information on the risks related to medicinal products supplied illegally to the public by means of information society services. This website shall contain a hyperlink to the website referred to in paragraph 5. L 174/84 5.The Agency shall set up a website providing the information referred to in points (b) and (d) of paragraph 4, information on the Union legislation applicable to falsified medicinal products as well as hyperlinks to the Member States websites referred to in paragraph 4. website shall explicitly mention that the Member States websites contain information on persons authorised or entitled to supply medicinal products at a distance to the public by means of information society services in the concerned. Without prejudice to Directive 2000/31/EC and the requirements set out in this Title, Member States shall take the necessary measures to ensure that other persons than those referred to in paragraph 1 that offer medicinal products for sale at a distance to the public by means of information society services and that operate on their territory are subject to effective, proportionate and dissuasive penalties. Without prejudice to the competences of the Member States, the Commission shall, in cooperation with the Agency and authorities, conduct or promote information campaigns aimed at the general public on the dangers of falsified medicinal products. Those campaigns shall raise consumer awareness of the risks related to medicinal products supplied illegally at a distance to the public by means of information society services and of the functioning of the common logo, the Member States websites and the Agencys website. (*)OJ L 204, 21.7.1998, p. (**)OJ L 178, , p. (21)Article 111 is amended as follows: (a)paragraph 1 is replaced by the following: The competent authority of the concerned shall, in cooperation with the Agency, ensure that the legal requirements governing medicinal products are complied with, by means of inspections, if necessary unannounced, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples. This coop eration shall consist in sharing information with the Agency on both inspections that are planned and that have been conducted. Member States and the Agency shall cooperate in the coordination of inspections in third countries. The inspections shall include but not be limited to the ones mentioned in paragraphs 1a to 1f. Manufacturers, located in the Union or in third countries, and wholesale distributors of medicinal products shall be subject to repeated inspections. The competent authority of the concerned shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of substances, located on its territory, and effective follow-up thereof. Whenever it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this Directive, including the principles and guidelines of good manufacturing practice and good distribution practices referred to in point (f) of Article 46 and in Article 47, the competent authority may carry out inspections at the premises of: (a)manufacturers or distributors of substances located in third countries; (b)manufacturers or importers of excipients. Inspections referred to in paragraphs 1a and 1b may also be carried out in the Union and in third countries at the request of a , the Commission or the Agency. Inspections may also take place at the premises of marketing authorisation holders and of brokers of medicinal products. In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of Pharmacopoeia, the standardisation body of the nomenclatures and the quality norms within the meaning of the Convention relating to the elaboration of Phar macopoeia (Directorate for the Quality of Medicines and Healthcare) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph. The competent authority of the concerned may carry out inspections of starting material manufacturers at the specific request of the manufacturer. Inspections shall be carried out by officials representing the competent authority who shall be empowered to: (a)inspect the manufacturing or commercial estab lishments of manufacturers of medicinal products, of substances or of excipients, and any laboratories employed by the holder of the manu facturing authorisation to carry out checks pursuant to Article 20; (b)take samples including with a view to independent tests being carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by a Member State; (c)examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 1975 placing restrictions on these powers with regard to the description of the manufacturing method; L 174/85 (d)inspect the premises, records, documents and phar macovigilance system file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX. Inspections shall be carried out in accordance with the guidelines referred to in Article 111a. (b) paragraphs 3 to 6 are replaced by the following: After every inspection as referred to in paragraph 1, the competent authority shall report on whether the inspected entity complies with the prin ciples and guidelines of good manufacturing practice and good distribution practices referred to in Articles 47 and 84, as applicable, or on whether the marketing authorisation holder complies with the requirements laid down in Title IX. The competent authority which carried out the inspection shall communicate the content of those reports to the inspected entity. Before adopting the report, the competent authority shall give the inspected entity concerned the oppor tunity to submit comments. 4.Without prejudice to any arrangements which may have been concluded between the Union and third countries, a , the Commission or the Agency may require a manufacturer established in a third country to submit to an inspection as referred to in this Article. 5.Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice or good distribution practices shall, when applicable, be issued to the inspected entity if the outcome of the inspection shows that it complies with the principles and guidelines of good manufac practice or good distribution practices as provided for by Union legislation. If inspections are performed as part of the certification procedure for the monographs of Phar macopoeia, a certificate shall be drawn up. Member States shall enter the certificates of good manufacturing practice and good distribution practices which they issue in a Union database managed by the Agency on behalf of the Union. Pursuant to Article 52a(7), Member States shall also enter information in that database regarding the registration of importers, manufacturers and distributors of substances. The database shall be publicly accessible. (c)paragraph 7 is amended as follows: (i)the words paragraph 1 are replaced by the words paragraph ; (ii)the words used as starting materials are deleted; (d)in the first subparagraph of paragraph 8, the words paragraph 1(d) are replaced by the words point (d) of paragraph ; (22)the following Articles are inserted: The Commission shall adopt detailed guidelines laying down the principles applicable to inspections referred to in Article 111. Member States shall, in cooperation with the Agency, establish the form and content of the authorisation referred to in Articles 40(1) and 77(1), of the reports referred to in Article 111(3), of the certificates of good manufacturing practice and of the certificates of good distribution practices referred to in Article 111(5). At the request of a third country, the Commission shall assess whether that countrys regulatory framework applicable to substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union. If the assessment confirms such equivalence, the Commission shall adopt a decision to include the third country in a list. The assessment shall take the form of a review of relevant documentation and, unless arrangements as referred to in Article 51(2) of this Directive are in place that cover this area of activity, that assessment shall include an on-site review of the third countrys regulatory system and, if necessary, an observed inspection of one or more of the third countrys manufacturing sites for substances. In the assessment particular account shall be taken of: (a)the countrys rules for good manufacturing practice; (b)the regularity of inspections to verify compliance with good manufacturing practice; (c)the effectiveness of enforcement of good manufac practice; (d)the regularity and rapidity of information provided by the third country relating to non-compliant producers of substances. 2.The Commission shall adopt the necessary imple menting acts to apply the requirements set out in points (a) to (d) of paragraph 1 of this Article. Those imple menting acts shall be adopted in accordance with the procedure referred to in Article 121(2). 3.The Commission shall verify regularly whether the conditions laid down in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the country has been included in the list referred to in paragraph 1. L 174/86 The Commission shall perform the assessment and verification referred to in paragraphs 1 and 3 in coop eration with the Agency and the competent authorities of the Member States. (23)in Article 116, the following paragraph is added: