Changes from plenary report to adopted text

Added1. Each Member State shall take all the appropriate measures to ensure that decisions granting marketing authorisation, refusing or revoking a marketing authorisation, cancelling a decision refusing or revoking a marketing authorisation, prohibiting supply, or withdrawing a product from the market, together with the reasons on which such decisions are based, are brought to the attention of the Agency without undue delay.

Added2. In addition to the notification made pursuant to Article 116 of [revised Regulation (EC) No 726/2004], the marketing authorisation holder shall declare without undue delay if such notified action is based on any of the grounds set out in Articles 195 or 196(1).

Added3. The marketing authorisation holder shall also make the notification pursuant to paragraph 2 in cases where the action is taken in a third country and where such action is based on any of the grounds set out Articles 195 or 196(1).

Added4. The marketing authorisation holder shall furthermore notify the Agency where the action referred to in paragraphs 2 or 3 is based on any of the grounds referred to in Articles 195 or 196(1).

Added5. The Agency shall forward notifications received in accordance with paragraph 4 to all Member States without undue delay.

Added6. Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 that may affect the protection of public health in third countries is without undue delay brought to the attention of the World Health Organization, with a copy to the Agency.

Added7. Each year, the Agency shall make public a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended in the Union, whose supply has been prohibited or that have been withdrawn from the market, including the reasons for such action.

AddedArticle 204 Notification of decisions related to marketing authorisations

Added1. Every decision referred to in this Directive that is taken by the competent authority of a Member State shall state in detail the reasons on which it is based.

Added2. Such decision shall be notified to the party concerned, together with information as to the redress available to them under the laws in force and of the time limit allowed for access to such redress.

Added3. Decisions to grant or revoke a marketing authorisation shall be made publicly available.

AddedArticle 205 Authorisation of a medicinal product on public health grounds

Added1. In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in accordance with Chapter III, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product.

Added2. When a Member State avails itself of this possibility, it shall adopt the necessary measures in order to ensure that the requirements of this Directive are complied with, in particular those referred to in Chapters IV, VI, IX, XIII and XIV, and Article 206. Member States may decide that Article 74, paragraphs 1 to 3, shall not apply to medicinal products authorised under paragraph 1.

Added3. Before granting such a marketing authorisation, a Member State:

Added(a) shall notify the marketing authorisation holder, in the Member State in which the medicinal product concerned is authorised, of the proposal to grant a marketing authorisation under this Article in respect of the medicinal product concerned;

Added(b) may request the competent authority in that Member State to submit copies of the assessment report referred to in Article 43(5) and of the marketing authorisation in force in respect of the medicinal product concerned. If so requested, the competent authority in that Member State shall supply, within 30 days of receipt of the request, a copy of the assessment report and the marketing authorisation in respect of the medicinal product concerned.

Added4. The Commission shall set up a publicly available register of medicinal products authorised under paragraph 1. Member States shall notify the Commission if any medicinal product is authorised, or ceases to be authorised, under paragraph 1, including the name or corporate name and permanent address of the marketing authorisation holder. The Commission shall amend the register of medicinal products accordingly and make this register available on their website.

AddedArticle 206 Penalties

Added1. Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.

AddedThose penalties shall not be inferior to those applicable to infringements of national law of similar nature and importance.

Added1a. When determining the type and level of penalties to be imposed in the case of infringements, the competent authorities of the Member States shall give due regard to all relevant circumstances of the specific infringement and to the following:

Added(a) the nature, gravity and extent of the infringement;

Added(b) the repetitive or singular character of the infringement;

Added(c) where appropriate, the intentional or negligent character of the infringement;

Added(d) any action taken by the infringing party to mitigate or remedy the damage caused;

Added(e) the level of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement. [Am. 316]

Added2. The rules referred to in paragraph 1, first subparagraph, shall address, inter alia, the following:

Added(a) the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well as sale at distance of falsified medicinal products to the public;

Added(b) non-compliance with the provisions laid down in this Directive on manufacturing, distribution, import and export of active substances;

Added(c) non-compliance with the provisions laid down in this Directive on the use of excipients;

Added(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance;

Added(e) non-compliance with the provisions laid down in this Directive on advertising.

Added(ea) non-compliance with the obligations set out in Article 58a shall be subject to the imposition of effective, proportionate and dissuasive financial penalties. [Am. 317]

Added3. Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.

AddedArticle 207 Collection and management of unused or expired medicinal products [Am. 318]

AddedMember States shall ensure that appropriate collection and management systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment. [Am. 319]

Added1a. By ... [18 months from the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to:

Added(a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products;

Added(b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2);

Added(c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2);

Added(d) increase the rate of correct disposal of unused or expired medicinal products; and

Added(e) designate public or private actors, or both, responsible for the collection systems referred to in paragraph 1. [Am. 320]

Added1b. Member States shall submit the national plans to the Commission. [Am. 321]

AddedArticle 208 Declaration of interests

Added1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality and their independence. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary. The declaration shall be made available upon request. [Am. 322]

Added2. In addition, the Member States shall ensure that the competent authority makes publicly available its rules of procedure and those of its committees, including their working groups and expert groups, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions. [Am. 323]

AddedChapter XVII Specific provisions concerning Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland

AddedArticle 209 Provisions relevant to the United Kingdom in respect of Northern Ireland

Added1. By way of derogation from Article 5, the competent authorities of the United Kingdom in respect of Northern Ireland may temporarily authorise the supply to patients in Northern Ireland of a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 of [revised Regulation (EC) No 726/2004] provided that all of the following conditions are fulfilled:

Added(a) the medicinal product concerned has been granted a marketing authorisation by the competent authority of the United Kingdom for parts of the United Kingdom other than Northern Ireland;

Added(b) the medicinal product concerned is only made available to patients or end-consumers in the territory of Northern Ireland and is not made available in any Member State.

AddedThe maximum validity of the temporary authorisation shall be six months.

AddedNotwithstanding the specified validity, the temporary authorisation shall cease to be valid if the medicinal product concerned has been granted a marketing authorisation in accordance with Article 13 of [revised Regulation (EC) No 726/2004], or if such marketing authorisation has been refused in accordance with that Article.

Added2. By way of derogation from Article 56(4), marketing authorisations may be granted by the competent authorities of the United Kingdom in respect of Northern Ireland:

Added(a) to applicants established in parts of the United Kingdom other than Northern Ireland;

Added(b) to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland, in accordance with the mutual recognition or the decentralised procedure laid down in Chapter III, Sections 3 and 4.

AddedThe competent authorities of the United Kingdom in respect of Northern Ireland may extend marketing authorisations already granted prior to 20 April 2022 to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

Added3. By way of derogation from Article 33, paragraphs 1, 3 and 4 and Article 35(1), if an application for marketing authorisation is submitted in one or more Member States and in the United Kingdom in respect of Northern Ireland, or if an application for marketing authorisation is submitted in the United Kingdom in respect of Northern Ireland for a medicinal product that is already being examined or has already been authorised in a Member State, the application regarding the United Kingdom in respect of Northern Ireland shall not have to be submitted in accordance with Chapter III, Sections 3 and 4, provided that all of the following conditions are fulfilled:

Added(a) the marketing authorisation for the United Kingdom in respect of Northern Ireland is granted by the competent authority for the United Kingdom in respect of Northern Ireland in compliance with Union law, and such compliance with Union law is ensured during the period of validity of that marketing authorisation;