What changed between the plenary report and the adopted text

Added:(iii) the batch number. [Am. 186]

Added:3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 65 and 73 cannot be displayed, shall include at least the following labelling particulars:

Added:(a) the name of the medicinal product and, if necessary, the route of administration;

Added:(b) the method of administration;

Added:(c) the expiry date;

Added:(d) the batch number;

Added:(e) the contents by weight, by volume or by unit.

Added:Article 67 Safety features

Added:1. Medicinal products subject to prescription shall bear the safety features referred to in Annex IV, unless they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b).

Added:Medicinal products not subject to prescription shall not bear the safety features referred to in Annex IV, unless, by way of exception, they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b), or where the marketing authorisation holder chooses to do so voluntarily. [Am. 187]

Added:2. The Commission shall adopt delegated acts in accordance with Article 215 to supplement Annex IV by laying down detailed rules for the safety features.

Added:Those delegated acts shall set out:

Added:(a) the characteristics and technical specifications of the unique identifier of the safety features referred to in Annex IV that enables the authenticity of medicinal products to be verified and individual packs to be identified;

Added:(b) the lists containing the medicinal products or product categories that, 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 Annex IV;

Added:(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);

Added:(d) the modalities for the verification of the safety features referred to in Annex IV by the manufacturers, wholesale distributors, pharmacists and natural or legal persons authorised or entitled to supply medicinal products to the public and by the competent authorities;

Added:(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 Annex IV, shall be contained.

Added:The lists referred to in the second subparagraph, point (b), shall be established considering the risk of falsification relating to the medicinal products or categories of medicinal products concerned. To this end, at least the following criteria shall be applied:

Added:(a) the price and sales volume of the medicinal product;

Added:(b) 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;

Added:(c) the specific characteristics of the medicinal products concerned;

Added:(d) the severity of the conditions intended to be treated;

Added:(e) other potential risks to public health.

Added:The modalities referred to in the second subparagraph, point (d), shall allow the verification of the authenticity of each supplied pack of the medicinal products bearing the safety features referred to in Annex IV 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.

Added:For the purposes of the second subparagraph, point (e), the costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features.

Added:3. When adopting delegated acts referred to in paragraph 2, the Commission shall take due account of at least the following:

Added:(a) the protection of personal data as provided for in Union law;

Added:(b) the legitimate interests to protect information of a commercially confidential nature;

Added:(c) the ownership and confidentiality of the data generated by the use of the safety features; and

Added:(d) the cost-effectiveness of the measures.

Added:4. The competent authorities of the Member States shall notify the Commission of non-prescription medicinal products that they judge to be at risk of falsification and may inform the Commission of medicinal products that they deem not to be at risk of falsification in accordance with the criteria set out in paragraph 2, second subparagraph, point (b).

Added:5. Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in Annex IV to any medicinal product subject to prescription or subject to reimbursement.

Added:6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology or for data protection prolongation for market launch use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).

Added:7. Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in Annex IV to any medicinal product.

Added:7a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging. [Am. 188]

Added:Article 68 Labelling and instruction leaflet of radionuclides and radiopharmaceuticals

Added:1. In addition to the rules laid down in this Chapter, the outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling shall comply with the provisions set out in paragraphs 2 and 3.

Added:2. The label on the shielding shall include the particulars laid down in Article 65. In addition, the label on the shielding shall explain in full, the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.

Added:3. The vial shall be labelled with the following information:

Added:(a) the name or code of the medicinal product, including the name or chemical symbol of the radionuclide;

Added:(b) the batch identification and expiry date;

Added:(c) the international symbol for radioactivity;

Added:(d) the name and address of the manufacturer;

Added:(e) the amount of radioactivity as specified in paragraph 2.

Added:4. The competent authority shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors. The text of this leaflet shall be established in accordance with Article 64(1). In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents.

Added:Article 69 Special information requirements for antimicrobials

Added:1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, including through medical sales representatives as referred to in Article 175(1), point (c), regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial. Any informational material shall be compatible with the summary of product characteristics. [Am. 189]

Added:2. The marketing authorisation holder shall include in the packaging of antimicrobials a document that contains specific information about the medicinal product concerned and that is made available to the patient in addition to the product leaflet (“awareness card”) with information on antimicrobial resistance and the appropriate use and disposal of antimicrobials.

Added:Member States may decideshall ensure that the awareness card shall beis made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, an awareness cardboth in paper format shall be includedand electronically in the packaging of an antimicrobial. [Am. 190]

Added:3. The text of the awareness card shall be aligned with Annex VI.

Added:Members States shall introduce appropriate disposal systems for antimicrobials in the community setting, and inform the general public on the correct disposal methods for antimicrobial. [Am. 191]

Added:3a. The Commission may adopt implementing acts laying down further standards for the awareness card after consulting the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). [Am. 192]

Added:Article 70 Legibility

Added:The package leaflet and labelling particulars referred to in this Chapter shall be easily legible, clearly comprehensible and indelible.

Added:Article 71 Accessibility for persons with disabilities

Added:The name of the medicinal product shall also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package leaflet referred to in Article 63 is made available upon request from patients' organisations in formats appropriate for persons with disabilities, including blind and partially-sighted persons.

Added:Article 72 Member States labelling requirements

Added:1. Notwithstanding Article 77 Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:

Added:(a) the price of the medicinal product;

Added:(b) the reimbursement conditions of social security organisations;