prop · H00340 · 2012-11-12 00:00:00 — (22)When examining the compatibility with Union law of the conditions for the retail supply of medicinal products, the Court of of Union (the Court of ) has recognised the very particular nature of medicinal products, whose therapeutic effects distinguish them substantially from other goods. The Court of has also held that health and life of humans rank foremost among the assets and interests protected by the TFEU and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one to another, Member States must be allowed discretion (1) as regards the conditions for the supply on their territory of medicinal products to the public. (23)In particular, in the light of the risks to public health and given the power accorded to Member States to determine the level of protection of public health, the case-law of the Court of has recognised that Member States may, in principle, restrict the retail sale of medicinal products to pharmacists alone (2). (1) Judgment of the Court of 19 2009 in Joined Cases C-171/07 and C-172/07 Apothekerkammer des Saarlandes and Others v ECR [2009] I-4171, paragraphs 19 and 31. (2) Judgment of the Court of 19 2009 in Joined Cases C-171/07 and C-172/07 Apothekerkammer des Saarlandes and Others v ECR [2009] I-4171, paragraphs 34 and 35. (24)Therefore, and in the light of the case-law of the Court of , Member States should be able to impose conditions justified by the protection of public health upon the retail supply of medicinal products offered for sale at a distance by means of information society services. Such conditions should not unduly restrict the functioning of the internal market. (25)The public should be assisted in identifying websites which are legally offering medicinal products for sale at a distance to the public. A common logo should be established, which is recognisable throughout the Union, while allowing for the identification of the where the person offering medicinal products for sale at a distance is established. The Commission should develop the design for such a logo. Websites offering medicinal products for sale at a distance to the public should be linked to the website of the competent authority concerned. The websites of the competent authorities of Member States, as well as that of (the Agency), should give an explanation of the use of the logo. All those websites should be linked in order to provide comprehensive information to the public. (26)In addition, the Commission should, in cooperation with the Agency and Member States, run awareness campaigns to warn of the risks of purchasing medicinal products from illegal sources via the Internet. (27)Member States should impose effective penalties for acts involving falsified medicinal products taking into account the threat to public health posed by those products. (28)The falsification of medicinal products is a global problem, requiring effective and enhanced international coordination and cooperation in order to ensure that anti-falsification strategies are more effective, in particular as regards sale of such products via the Internet. To that end, the Commission and the Member States should cooperate closely and support ongoing work in inter national fora on this subject, such as , Europol and the United Nations. In addition, the Commission, working closely with Member States, should cooperate with the competent authorities of third countries with a view to effectively combating the trade in falsified medicinal products at a global level. (29)This Directive is without prejudice to provisions concerning intellectual property rights. It aims specifically to prevent falsified medicinal products from entering the legal supply chain. (30)The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions of Directive 2001/83/EC, as amended by this Directive, concerning manufacturing and distribution practices for substances, concerning detailed rules for medicinal products introduced into the Union without being imported and concerning safety features. It is of particular importance that the Commission carry L 174/77 out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to Parliament and Council. (31)In order to ensure uniform conditions for implemen tation, implementing powers should be conferred on the Commission as regards the adoption of measures for the assessment of the regulatory framework applicable to the manufacturing of substances exported from third countries to the Union and as regards a common logo that identifies websites which are legally offering medicinal products for sale at a distance to the public. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of Parliament and of 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commissions exercise of implementing powers (1). (32)The safety features for medicinal products introduced under this Directive require substantial adaptations to manufacturing processes. In order to enable manu facturers to make those adaptations, the time limits for the application of the provisions on the safety features should be sufficiently long and should be calculated as from the date of publication in the delegated acts setting out detailed rules in relation to those safety features. It should also be taken into account that some Member States already have a national system in place. Those Member States should be granted an additional transitional period for adapting to the harmonised Union system. (33)Since the objective of this Directive, namely to safeguard the functioning of the internal market for medicinal products, whilst ensuring a high level of protection of public health against falsified medicinal products, cannot be sufficiently achieved by the Member States, and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (34)It is important that the competent authorities of the Member States, the Commission and the Agency cooperate to ensure the exchange of information on measures taken to combat the falsification of medicinal products and on the penalties systems that are in place. Currently, such exchange takes place through the Officers. Member States should ensure that patients and consumers organisations are kept informed about enforcement activities to the extent that this is compatible with oper ational needs. (1) OJ L 55, 28.2.2011, p. (35)In accordance with point 34 of the Interinstitutional Agreement on better law-making (2), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (36)Directive 2001/83/EC was recently amended by Directive 2010/84/EU (3) as regards pharmacovigilance. That Directive, inter alia, amended Article 111 with regard to inspections and Article 116 with regard to the suspension and revocation and variation of marketing authorisations under certain circumstances. Furthermore, it inserted provisions on delegated acts in Articles 121a, 121b and 121c of Directive 2001/83/EC. This Directive requires some further and complementary changes to those Articles of Directive 2001/83/EC. (37)Directive 2001/83/EC should be amended accordingly, Directive 2001/83/EC is hereby amended as follows: (1)Article 1 is amended as follows: (a)the following points are inserted: 3a. substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an ingredient of that product intended to exert a pharmacological, immuno logical or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a diagnosis. constituent of a medicinal product other than the substance and the packaging material. (b)the following point is inserted: Brokering of medicinal products: All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating inde pendently and on behalf of another legal or natural person. (c)the following point is added: 33. Falsified medicinal product: (2) OJ C 321, 31.12.2003, p. (3) OJ L 348, 31.12.2010, p. L 174/78 medicinal product with a false representation of: (a)its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b)its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c)its history, including the records and documents relating to the distribution channels used. This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights. (2)in Article 2, paragraph 3 is replaced by the following: Notwithstanding paragraph 1 of this Article and Article 3(4), Title IV of this Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, substances and excipients. Paragraph 1 shall be without prejudice to Articles 52b and 85a. (3)in Article 8(3), the following point is inserted: (ha) A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice. (4)in Article 40, paragraph 4 is replaced by the following: Member States shall enter the information relating to the authorisation referred to in paragraph 1 of this Article in the Union database referred to in Article 111(6). (5)in Article 46, point (f) is replaced by the following: (f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use only substances, which have been manu factured in accordance with good manufacturing practice for substances and distributed in accordance with good distribution practices for substances. To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manu facturer and distributors of substances. holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in this Directive, through an entity acting on his behalf under a contract. The holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appro priate good manufacturing practice is. This shall be ascertained on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the fifth paragraph of Article 47. Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The holder of the manufacturing auth orisation shall ensure that the appropriate good manufacturing practice so ascertained, is applied. The holder of the manufacturing authorisation shall document the measures taken under this paragraph; (g)to inform the competent authority and the marketing authorisation holder immediately if he obtains information that medicinal products which come under the scope of his manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services; (h)to verify that the manufacturers, importers or distributors from whom he obtains substances are registered with the competent authority of the in which they are established; (i)to verify the authenticity and quality of the substances and the excipients. (6)the following Article is inserted: 1.Member States shall take appropriate measures to ensure that the manufacture, import and distribution on their territory of substances, including substances that are intended for export, comply with good manufacturing practice and good distribution practices for substances. 2.Active substances shall only be imported if the following conditions are fulfilled: (a)the substances have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47; and (b)the substances are accompanied by a written confirmation from the competent authority of the exporting third country of the following: L 174/79 (i)the standards of good manufacturing practice applicable to the plant manufacturing the exported substance are at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47; (ii)the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and (iii)in the event of findings relating to noncompliance, information on such findings is supplied by the exporting third country to the Union without any delay. This written confirmation shall be without prejudice to the obligations set out in Article 8 and in point (f) of Article 46. 3.The requirement set out in point (b) of paragraph 2 of this Article shall not apply if the exporting country is included in the list referred to in Article 111b. 4.Exceptionally and where necessary to ensure the availability of medicinal products, when a plant manufac an substance for export has been inspected by a and was found to comply with the principles and guidelines of good manufacturing practice laid down pursuant to the third paragraph of Article 47, the requirement set out in point (b) of paragraph 2 of this Article may be waived by any for a period not exceeding the validity of the certificate of Good facturing Practice. Member States that make use of the possibility of such waiver, shall communicate this to the Commission. (7)in Article 47, the third and fourth paragraphs are replaced by the following: The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, the prin ciples and guidelines of good manufacturing practice for substances referred to in the first paragraph of point (f) of Article 46 and in Article 46b. The principles of good distribution practices for substances referred to in the first paragraph of point (f) of Article 46 shall be adopted by the Commission in the form of guidelines. The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in the second paragraph of point (f) of Article 46.; (8)the following Article is inserted: The safety features referred to in point (o) of Article 54 shall not be removed partially, unless the following (a)the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with; (b)the manufacturing authorisation holder complies with point (o) of Article 54 by replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identi fication and to provide evidence of tampering of the medicinal product. Such replacement shall be conducted without opening the immediate packaging as defined in point 23 of Article 1. Safety features shall be considered equivalent if they: (i)comply with the requirements set out in the delegated acts adopted pursuant to Article 54a(2); and (ii)are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products; (c)the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and (d)the replacement of the safety features is subject to supervision by the competent authority. 2.Manufacturing authorisation holders, including those performing the activities referred to in paragraph 1 of this Article, shall be regarded as producers and therefore held liable for damages in the cases and under the conditions set forth in Directive 85/374/EEC. (9)in Article 51(1), the following subparagraph is inserted before the second subparagraph: The qualified person referred to in Article 48 shall in the case of medicinal products intended to be placed on the market in the Union, ensure that the safety features referred to in point (o) of Article 54 have been affixed on the packaging. (10)the following Articles are inserted: 1.Importers, manufacturers and distributors of substances who are established in the Union shall register their activity with the competent authority of the in which they are established. The registration form shall include, at least, the following information: (i)name or corporate name and permanent address; (ii)the substances which are to be imported, manu factured or distributed; (iii)particulars regarding the premises and the technical equipment for their activity. L 174/80 3.The persons referred to in paragraph 1 shall submit the registration form to the competent authority at least 60days prior to the intended commencement of their activity. 4.The competent authority may, based on a risk assessment, decide to carry out an inspection. competent authority notifies the applicant within 60 days of the receipt of the registration form that an inspection will be carried out, the activity shall not begin before the competent authority has notified the applicant that he may commence the activity. If within 60 days of the receipt of the registration form the competent authority has not notified the applicant that an inspection will be carried out, the applicant may commence the activity. The persons referred to in paragraph 1 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in the registration form. changes that may have an impact on the quality or safety of the substances that are manu factured, imported or distributed must be notified immediately. 6.Persons referred to in paragraph 1 who had commenced their activity before 2 January 2013 shall submit the registration form to the competent authority by 2 2013. 7.Member States shall enter the information provided in accordance with paragraph 2 of this Article in the Union database referred to in Article 111(6). This Article shall be without prejudice to Article 111. 1.Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall take the necessary measures in order to prevent medicinal products that are introduced into the Union, but are not intended to be placed on the market of the Union, from entering into circulation if there are sufficient grounds to suspect that those products are falsified. 2.In order to establish what the necessary measures referred to in paragraph 1 of this Article are, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions laid down in Articles 121b and 121c, measures supplementing paragraph 1 of this Article as regards the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced into the Union but not intended to be placed on the market. (11)in Article 54, the following point is added: (o) for medicinal products other than radiophar maceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to: verify the authenticity of the medicinal product, and identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with. (12)the following Article is inserted: Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article. Medicinal products not subject to prescription shall not bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification. The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article 54. Those delegated acts shall set out: (a)the characteristics and technical specifications of the unique identifier of the safety features referred to in point (o) of Article 54 that enables the authenticity of medicinal products to be verified and individual packs to be identified. When establishing the safety features due consideration shall be given to their cost-effec tiveness; (b)the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54. Those lists shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products. To this end, at least the following criteria shall be applied: (i)the price and sales volume of the medicinal product; (ii)the number and frequency of previous cases of falsified medicinal products being reported within the Union and in third countries and the evolution of the number and frequency of such cases to date; (iii)the specific characteristics of the medicinal products concerned; (iv)the severity of the conditions intended to be treated; (v)other potential risks to public health; L 174/81 (c)the procedures for the notification to the Commission provided for in paragraph 4 and a rapid system for evaluating and deciding on such notification for the purpose of applying point (b);