Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Text with EEA relevance

‘3 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, active substances and excipients.

4 Paragraph 1 shall be without prejudice to Articles 52b and 85a.’;

‘4 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).’;

1 Member States shall take appropriate measures to ensure that the manufacture, import and distribution on their territory of active substances, including active substances that are intended for export, comply with good manufacturing practice and good distribution practices for active substances.

2 Active substances shall only be imported if the following conditions are fulfilled: (a) the active 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 active substances are accompanied by a written confirmation from the competent authority of the exporting third country of the following: (i) the standards of good manufacturing practice applicable to the plant manufacturing the exported active 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 non-compliance, 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 manufacturing an active substance for export has been inspected by a Member State 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 Member State for a period not exceeding the validity of the certificate of Good Manufacturing Practice. Member States that make use of the possibility of such waiver, shall communicate this to the Commission.’;

1 The safety features referred to in point (o) of Article 54 shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled: (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, identification 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.’;

1 Importers, manufacturers and distributors of active substances who are established in the Union shall register their activity with the competent authority of the Member State in which they are established.

2 The registration form shall include, at least, the following information: (i) name or corporate name and permanent address; (ii) the active substances which are to be imported, manufactured or distributed; (iii) particulars regarding the premises and the technical equipment for their activity.

3 The persons referred to in paragraph 1 shall submit the registration form to the competent authority at least 60 days prior to the intended commencement of their activity.

4 The competent authority may, based on a risk assessment, decide to carry out an inspection. If the 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.

5 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. Any changes that may have an impact on the quality or safety of the active substances that are manufactured, 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 March 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).

8 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.’;

1 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.

2 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-effectiveness; (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; (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); (d) the modalities for the verification of the safety features referred to in point (o) of Article 54 by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public and by the competent authorities. Those modalities shall allow the verification of the authenticity 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 establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained. The costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features.

3 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 reimbursement 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.’;

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.

1 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 Member State 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, communication 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.

2 Persons may only broker medicinal products if they are registered with the competent authority of the Member State 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 March 2013. The competent authority shall enter the information referred to in the first subparagraph in a register that shall be publicly accessible.

3 The guidelines referred to in Article 84 shall include specific provisions for brokering.

4 This Article shall be without prejudice to Article 111. Inspections referred to in Article 111 shall be carried out under the responsibility of the Member State where the person brokering medicinal products is registered. 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.’;

1 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 the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society 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 Member State in which that person is established; (b) the person referred to in point (a) has notified the Member State 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 legislation of the Member State of destination in accordance with Article 6(1); (d) without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 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 Member State of establishment; (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 recognisable throughout the Union, while enabling the identification of the Member State 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).

4 Each Member State shall 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.

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. The Agency’s 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 Member State concerned.

6 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 Member State 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 Agency’s website.

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).

1 At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active 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 country’s regulatory system and, if necessary, an observed inspection of one or more of the third country’s manufacturing sites for active substances. In the assessment particular account shall be taken of: (a) the country’s rules for good manufacturing practice; (b) the regularity of inspections to verify compliance with good manufacturing practice; (c) the effectiveness of enforcement of good manufacturing practice; (d) the regularity and rapidity of information provided by the third country relating to non-compliant producers of active substances.

2 The Commission shall adopt the necessary implementing acts to apply the requirements set out in points (a) to (d) of paragraph 1 of this Article. Those implementing 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.

4 The Commission shall perform the assessment and verification referred to in paragraphs 1 and 3 in cooperation with the Agency and the competent authorities of the Member States.’;

1 Member States shall have a system in place which aims at preventing medicinal products that are suspected to present a danger to health from reaching the patient.

2 The system referred to in paragraph 1 shall cover the receipt and handling of notifications of suspected falsified medicinal products as well as of suspected quality defects of medicinal products. The system shall also cover recalls of medicinal products by marketing authorisation holders or withdrawals of medicinal products from the market ordered by national competent authorities from all relevant actors in the supply chain both during and outside normal working hours. The system shall also make it possible to recall, where necessary with the assistance of health professionals, medicinal products from patients who received such products.

3 If the medicinal product in question is suspected of presenting a serious risk to public health, the competent authority of the Member State in which that product was first identified shall, without any delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.

4 Member States shall by 22 July 2013 notify the Commission of the details of their respective national systems referred to in this Article.’;

1 The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that those penalties are implemented. The penalties must be effective, proportionate and dissuasive. Those penalties shall not be inferior to those applicable to infringements of national law of similar nature and importance.

2 The rules referred to in paragraph 1 shall address, inter alia, the following: (a) the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well as the sale of falsified medicinal products at a distance to the public by means of information society services; (b) non-compliance with the provisions laid down in this Directive on manufacturing, distribution, import and export of active substances; (c) non-compliance with the provisions laid down in this Directive on the use of excipients. Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.

3 The Member States shall notify the national provisions adopted pursuant to this Article to the Commission by 2 January 2013 and shall notify any subsequent amendment of those provisions without delay. By 2 January 2018, the Commission shall submit a report to the European Parliament and to the Council giving an overview of the transposition measures of Member States as regards this Article, together with an evaluation of the effectiveness of those measures.

Member States shall organise meetings involving patients “and consumers” organisations and, as necessary, Member States’ enforcement officers, in order to communicate public information about the actions undertaken in the area of prevention and enforcement to combat the falsification of medicinal products.

Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.’;

1 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2 January 2013. They shall forthwith inform the Commission thereof.

2 Member States shall apply those measures from 2 January 2013. However, the Member States shall apply: (a) the provisions necessary to comply with point 6 of Article 1 of this Directive in so far as it relates to Article 46b(2)(b) and Article 46b(3) and (4) of Directive 2001/83/EC as inserted by this Directive from 2 July 2013; (b) the provisions necessary to comply with points 8, 9, 11 and 12 of Article 1 of this Directive from 3 years after the date of publication of the delegated acts referred to in point 12 of Article 1 of this Directive. Nevertheless, Member States which, on 21 July 2011, have systems in place for the purpose referred to in point 11 of Article 1 of this Directive shall apply the provisions necessary to comply with points 8, 9, 11 and 12 of Article 1 of this Directive at the latest from 6 years after the date of application of the delegated acts referred to in point 12 of Article 1 of this Directive; (c) the provisions necessary to comply with point 20 of Article 1 of this Directive in so far as it relates to Article 85c of Directive 2001/83/EC as inserted by this Directive at the latest from 1 year after the date of publication of the implementing acts referred to in Article 85c(3) as inserted by this Directive.

3 When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such references shall be laid down by Member States.

4 Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

At the latest 5 years after the date of application of the delegated acts referred to in Article 54a(2) of Directive 2001/83/EC as inserted by this Directive, the Commission shall submit a report to the European Parliament and to the Council containing the following: (a) a description, where possible including quantitative data, of the trends in the falsification of medicinal products in terms of: categories of medicinal products affected, distribution channels including sale at a distance to the public by means of information society services, the Member States concerned, the nature of the falsifications, and the regions of provenance of these products; and (b) an evaluation of the contribution of the measures provided for in this Directive regarding the prevention of the entry of falsified medicinal products in the legal supply chain. That evaluation shall in particular assess point (o) of Article 54 and Article 54a of Directive 2001/83/EC as inserted by this Directive.

In order to adopt the delegated acts referred to in Article 54a(2) of Directive 2001/83/EC as inserted by this Directive, the Commission shall perform a study assessing at least the following aspects: (a) the technical options for the unique identifier of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC as inserted by this Directive; (b) the options for the extent and the modalities of verification of the authenticity of the medicinal product bearing the safety features. This assessment shall take into account the particular characteristics of the supply chains in the Member States; (c) the technical options for establishing and managing the repositories system, referred to in point (e) of Article 54a(2) of Directive 2001/83/EC as inserted by this Directive. The study shall, for each of the options, assess benefits, costs and cost-effectiveness.

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Directive is addressed to the Member States.