Changes from plenary report to adopted text

Added1. When reference is made to the procedure laid down in this Article, the Committee for Medicinal Products for Human Use referred to in Article 148 of [revised Regulation (EC) No 726/2004] shall consider the matter concerned and shall issue a reasoned opinion within 60 days from the date when the matter was referred to it.

AddedHowever, in cases submitted to the Committee for Medicinal Products for Human Use in accordance with Articles 39, 40 and 95, this period may be extended by the Committee for Medicinal Products for Human Use for a further period of up to 90 days.

AddedOn a proposal from its chairperson, the Committee for Medicinal Products for Human Use may agree to a shorter deadline.

Added2. In order to consider the matter, the Committee for Medicinal Products for Human Use shall appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee for Medicinal Products for Human Use shall define their tasks and specify the time limit for the completion of these tasks.

Added3. Before issuing its opinion, the Committee for Medicinal Products for Human Use shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit which it shall specify.

AddedThe opinion of the Committee for Medicinal Products for Human Use shall be accompanied by a summary of product characteristics, the labelling and package leaflet.

AddedIf necessary, the Committee for Medicinal Products for Human Use may call upon any other person to provide information relating to the matter before it or consider a public hearing.

AddedThe Agency shall, in consultation with the parties concerned, draw up Rules of Procedure on the organisation and conduct of public hearings, in accordance with Article 163 of [revised Regulation (EC) No 726/2004].

AddedThe Committee for Medicinal Products for Human Use may suspend the time limits referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder to prepare explanations.

Added4. The Agency shall without undue delay inform the applicant or the marketing authorisation holder where the opinion of the Committee for Medicinal Products for Human Use provides that:

Added(a) the application does not satisfy the criteria for a marketing authorisation;

Added(b) the summary of product characteristics proposed by the applicant or the marketing authorisation holder in accordance with Article 62 is to be amended;

Added(c) the marketing authorisation is to be granted subject to certain conditions, that are considered essential for the safe and effective use of the medicinal product, including pharmacovigilance;

Added(d) a marketing authorisation is to be suspended, varied or revoked;

Added(e) the medicinal product satisfies the conditions set out in Article 83 regarding medicinal products addressing an unmet medical need.

AddedWithin 12 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of its intention to request a re-examination of the opinion. In that case, they shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.

AddedWithin 60 days following receipt of the grounds for the request, the Committee for Medicinal Products for Human Use shall re-examine its opinion in accordance with Article 12(2), third subparagraph, of [revised Regulation (EC) No 726/2004]. The reasons for the conclusion reached further to its re-examination shall be annexed to the assessment report referred to in Article 12(2), third subparagraph, of [revised Regulation (EC) No 726/2004].

Added5. Within 12 days after its adoption, the Agency shall forward the final opinion of the Committee for Medicinal Products for Human Use to the competent authorities of the Member States, to the Commission and to the applicant or the marketing authorisation holder, together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions.

AddedIn the event of an opinion in favour of granting or maintaining a marketing authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the final opinion:

Added(a) a summary of product characteristics, as referred to in Article 62;

Added(b) the details of any conditions affecting the marketing authorisation within the meaning of paragraph 4, first subparagraph, point (c);

Added(c) the details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product;

Added(d) the labelling and package leaflet.

AddedArticle 42 Commission decision

Added1. Within 12 days of receipt of the opinion of the Committee for Medicinal Products for Human Use, the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 214(1) a draft of the decision on the application, on the basis of the requirements set out in this Directive.

AddedIn duly justified cases, the Commission may return the opinion to the Agency for further consideration.

AddedWhere a draft decision envisages the granting of a marketing authorisation, it shall include or make reference to the documents referred to in Article 41(5), second subparagraph.

AddedWhere a draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences.

AddedThe Commission shall send the draft decision to the competent authorities of the Member States and the applicant or the marketing authorisation holder and make the decision, including the justification, publicly available. [Am. 154]

Added2. The Commission shall, by means of implementing acts, adopt a final decision within 12 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use.

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2) and (3).

Added3. Where a Member State raises important new questions of a scientific or technical nature that have not been addressed in the opinion delivered by the Agency, the Commission may refer the application back to the Agency for further consideration. In that case, the procedures set out in paragraphs 1 and 2 shall start again upon reception of the reply of the Agency.

Added4. The decision referred to in paragraph 2 shall be addressed to all Member States and forwarded for information to the applicant or the marketing authorisation holder. The Member States concerned and the reference Member State shall adopt a decision to either grant or revoke the marketing authorisation, or vary its terms as necessary to comply with the decision referred to in paragraph 2 within 30 days following its notification. In the decision to grant, suspend, revoke or vary the marketing authorisation, the Member States shall refer to the decision adopted pursuant to paragraph 2. They shall inform the Agency accordingly.

Added5. Where the scope of the procedure initiated under Article 95 includes medicinal products covered by centralised marketing authorisation pursuant to Article 95(2), third subparagraph, the Commission shall, where necessary, adopt decisions to vary, suspend or revoke the marketing authorisations or to refuse the renewal of the marketing authorisations concerned in accordance with this Article.

AddedSection 6 Results of examination of a national marketing authorisation application

AddedArticle 43 Granting of the national marketing authorisation

Added1. When a competent authority of the Member State grants a national marketing authorisation, it shall inform the applicant of the marketing authorisation of the summary of product characteristics, the package leaflet, the labelling as well as any conditions established in accordance with Articles 44 and 45 together with any deadlines for the fulfilment of those conditions.

Added2. The competent authorities of the Member States shall take all necessary measures to ensure that the information given in the summary of product characteristics is in conformity with that accepted when the national marketing authorisation is granted or subsequently.

Added3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship and access plan and special information requirements referred to in Article 17(1), points (a) and (b), as well as any conditions established in accordance with Articles 17, 44, 45 and any obligations imposed subsequently in accordance with Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised. [Am. 155]

Added4. The competent authority of the Member State may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation holder. On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product. The competent authority shall inform the marketing authorisation holder of its decision, including the grounds for that decision, without unnecessary delay. [Am. 156]

Added5. The competent authorities of the Member States shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and non-clinical tests, the clinical studies, the risk management system, the environmental risk assessment and the pharmacovigilance system of the medicinal product concerned.

Added6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each therapeutic indication applied for.

Added7. The public assessment report referred to in paragraph 5 shall include a summary written in a manner that is understandable to the public. The summary shall contain, in particular, a section relating to the conditions of use of the medicinal product.

AddedArticle 44 National marketing authorisation subject to conditions

Added1. A marketing authorisation for a medicinal product may be granted subject to one or more of the following conditions:

Added(a) to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system;

Added(b) to conduct post-authorisation safety studies;

Added(c) to comply with obligations on the recording or reporting of suspected adverse reactions that are stricter than those referred to in Chapter IX;

Added(d) any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

Added(e) the existence of an adequate pharmacovigilance system;

Added(f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed;

Added(g) in case of medicinal products for which, on duly justified grounds set out in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post-authorisation obligation to substantiate the clinical benefit; [Am. 157]

Added(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or public health, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

Added(i) to conduct post-authorisation studies to improve the safe and effective use of the medicinal product;

Added(j) where appropriate, to carry out medicinal product-specific validation studies to replace animal-based control methods with non-animal-based control methods.

AddedAn obligation to conduct post authorisation efficacy studies referred to in the first subparagraph, point (f), shall be based on the delegated acts adopted pursuant to Article 88.

Added2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph, where necessary.

AddedArticle 45 National marketing authorisation under exceptional circumstances

Added1. In exceptional circumstances where, in an application under Article 6 for a marketing authorisation of a medical product, or in an application under Article 92 for a new therapeutic indication of an existing marketing authorisation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the competent authority of the Member State may, by derogation to Article 6, grant an authorisation under Article 43, subject to specific conditions, where the following requirements are met:

Added(a) the applicant has demonstrated, in the application file, that there are objective and verifiable reasons not to be able to submit comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use based on one of the grounds set out in Annex II;