What changed between the plenary report and the adopted text

Added:(iii) undertakings that, by the time of granting the marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.

Added:The deadlines set out in the first subparagraph of this paragraph shall be prolonged by six months following the notification of the marketing authorisation holder to the competent authority. The marketing authorisation holder shall in such cases state the reasons for the delay. The marketing authorisation holder shall notify that it complied with the obligations set out in the first subparagraph of this paragraph through the EU Access to Medicines Notification System provided for in Article 58b.

Added:2. For the purposes of paragraph 1 of this Article, Member States shall make either their request or a notification that their request will be made at a later date within one year of the granting of a marketing authorisation. This shall be notified in the EU Access to Medicines Notification System provided for in Article 58b of this Directive, and for a notification that a request will be made at a later date be accompanied by a justification. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. Where a Member State has not complied with the time limits laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State.

Added:3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead to comply with the obligations set out in paragraph 1 only in the Member States where the relevant patient population has been identified.

Added:4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. A Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall be considered to be complied with in that Member State.

Added:5. The Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying criteria for the exemption of medicinal products from the obligations set out in this Article based on the nature of the medicinal product or its market. The delegated acts shall provide clarity to developers regarding the application of exemptions, and set out requirements related to impartiality and transparency in decisions of the implementing acts referred to in this Article. After consultation with the Agency, the Commission shall adopt, by means of implementing acts, a list of medicinal products to be exempted from the obligations set out in this Article. The inclusion of a medicinal product in that list shall, where relevant, take into account circumstances related to regulatory and reimbursement procedures pertaining to particular medicinal products, or to the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Added:6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder.

Added:7. The Commission shall, by means of implementing acts, establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential disputes related to the process for submission of applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). In the event of continued disagreement between an applicant and a Member State regarding compliance with the obligations set out in this Article, the Commission shall be empowered to issue a legally binding decision following an opinion of the Agency.

Added:8. This Article shall not prevent a marketing authorisation holder from submitting an application for pricing and reimbursement and placing a medicinal product on the market of a Member State without a Member State having made a request in accordance with paragraph 1. [Am. 174]

Added:Article 58b EU Access to Medicines Notification System

Added:1. The Commission shall set up and maintain an electronic notification system for the notification of compliance with the obligations set out in Article 58a (the ‘EU Access to Medicines Notification System’). The EU Access to Medicines Notification System shall be interoperable with other relevant Union-wide data repositories for medicinal products.

Added:2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a.

Added:3. By ... [3 years from the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Added:4. By ... [5 years from the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2) of this Directive. Anonymised data, aggregated to Member State level, from the EU Access to Medicines Notification System may be made public for the purpose of reporting on access in Article 86a. [Am. 175]

Added:Article 59 Placing on the market of products with paediatric indications

Added:Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those medicinal products have already been marketed with other therapeutic indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the medicinal product on the market taking into account the paediatric indication in all Member States where the medicinal product is already placed on the market.

Added:A register, coordinated by the Agency, and made publicly available, shall mention these deadlines.

Added:Article 60 Discontinuation of the placing on the market of paediatric products

Added:If a medicinal product is authorised for a paediatric indication and the marketing authorisation holder has benefited from rewards or incentives under Article 86 of this Directive or Article 93 of [revised Regulation (EC) No 726/2004], and these periods of protection have expired, and if the marketing authorisation holder intends to discontinue placing the medicinal product on the market, the marketing authorisation holder shall transfer the marketing authorisation to a third party or allow a third party, which has declared its intention to continue to place the medicinal product in question on the market, to use the pharmaceutical, non-clinical and clinical documentation contained in the file of the medicinal product on the basis of Article 14.

Added:The marketing authorisation holder shall inform the competent authorities of its intention to discontinue the placing on the market of the medicinal product no less than twelve months before the discontinuation. The competent authorities shall make this fact publicly available.

Added:Article 61 Liability of the marketing authorisation holder

Added:The marketing authorisation shall not affect the civil and criminal liability of the marketing authorisation holder.

Added:Chapter VI Product information and labelling

Added:Article 62 Summary of product characteristics

Added:1. The summary of product characteristics shall contain the particulars listed in Annex V.

Added:2. For marketing authorisations under Articles 9 and 11 and subsequent variations to such marketing authorisations, if one or more of the therapeutic indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used are still covered by patent law or a supplementary protection certificate for medicinal products at the time when the generic or biosimilar medicinal product was marketed, the applicant for an authorisation for a generic or biosimilar medicinal product may request not to include this information in their marketing authorisation.

Added:3. For all medicinal products, a standard text shall be included in the summary of product characteristics expressly asking healthcare professionals to report any suspected adverse reaction in accordance with the national reporting system referred to in Article 106(1). Different ways of reporting, including electronic reporting, shall be available in compliance with Article 106(1), second subparagraph.

Added:Article 63 General principles on package leaflet

Added:1. A package leaflet shall be mandatory for medicinal products.

Added:2. The package leaflet shall be written and designed in a clear and understandable way, enabling users to act appropriately, when necessary with the help of healthcare professionals.

Added:3. Member States may decide that for individual medicinal products, categories of medicinal products or for all medicinal products, the package leaflet shall be made available both in paper format and electronically or electronically only. In the latter case, the decision shall be made only following a consultation of patients, carers and other relevant stakeholders, or both. In the absence of such specific rules in a Member State, a package leaflet shall be made available electronically and be included in paper format shall be included in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients as well as written and designed in a clear and understandable way. [Am. 176]

Added:3a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet. [Am. 177]

Added:3b. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may be made available on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet. [Am. 178]

Added:4. By derogation from paragraphs 1 and 2, where the information required under Articles 64 and 73 is directly conveyed on the outer packaging or on the immediate packaging, a package leaflet shall not be required.

Added:4a. By way of derogation from paragraph 3, where the medicinal product is intended for dispensation and administration by a qualified healthcare professional rather than for self-administration by the patient, the package leaflet may be made available only electronically. [Am. 179]

Added:5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive]. [Am. 180]

Added:6. By ... [12 months from the date of entry into force of this Directive], the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. [Am. 181]

Added:6a. The Agency shall make available a system to accommodate the electronic product information after consultation with Member States and the relevant stakeholders. The system shall be available at the latest by [24 months from the date of entry into force of this Directive]. [Am. 182]

Added:7. WhereWhen accessing the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including for advertising or marketing activities. [Am. 183]

Added:Article 64 Content of package leaflet

Added:1. The package leaflet shall be drawn up in accordance with the summary of product characteristics, referred to in Article 62(1) and shall include the particulars listed in Annex VI.

Added:2. For all medicinal products, a standardised text shall be included, expressly asking patients to communicate any suspected adverse reaction to their doctor, pharmacist, healthcare professional or directly to the national reporting system referred to in Article 106(1), and specifying the different ways of reporting available (electronic reporting, postal address or others) in compliance with Article 106(1), second subparagraph.

Added:3. The package leaflet shall reflect the results of consultationsFollowing a consultation with target patient groups and other relevant stakeholders, the Commission shall adopt guidelines to ensure that itthe package leaflet is legible, clear and easy to use. [Am. 184]

Added:Article 65 Content of labelling particulars

Added:1. The outer packaging of medicinal products or, where there is no outer packaging, the immediate packaging, with the exception of the packaging referred to in Article 66, paragraphs 2 and 3, shall include the labelling particulars listed in Annex IV.

Added:2. The Commission is empowered to adopt delegated acts in accordance with Article 215 to:

Added:(a) amend the list of labelling particulars set out in Annex IV in order to take account of scientific progress or patient needs;

Added:(b) supplement Annex IV by setting out a reduced list of mandatory labelling particulars that shall appear on the outer packaging of multi-language packages.

Added:Article 66 Labelling of blister packs or small immediate packaging

Added:1. The particulars laid down in Annex IV shall appear on immediate packagings other than those referred to in the paragraphs 2 and 3 and shall allow, at the request of the national competent authorities, single dispensation, particularly in the event of a shortage or major public health issue. [Am. 185]

Added:2. The following particulars at least shall appear on immediate packagings that take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 65 and 73.

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

Added:(b) the name of the marketing authorisation holder placing the product on the market;

Added:(c) the expiry date;

Added:(d) the batch number.

Added:2a. Each single dose of the blister pack shall include the following labelling particulars:

Added:(a) the name of the medicinal product followed by its strength and pharmaceutical form;

Added:(b) a data matrix code in which the following information is encoded:

Added:(i) the Global Trading Index Number (GTIN);

Added:(ii) the expiry date;