Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Section 1 Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)

Article 42 Scope of the centralised marketing authorisation procedure

1. Centralised marketing authorisations shall be valid throughout the Union.

2. Centralised marketing authorisation procedure shall apply in respect of the following veterinary medicinal products:

(a) veterinary medicinal products developed by means of one of the following biotechnological processes:

(i)

recombinant DNA technology;

(ii)

controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells;

(iii)

hybridoma and monoclonal antibody methods;

(b) veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;

(c) veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;

(d) biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;

(e) novel therapy veterinary medicinal products.

3. Points (d) and (e) of paragraph 2 shall not apply to veterinary medicinal products consisting exclusively of blood components.

4. For veterinary medicinal products other than those referred to in paragraph 2, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.

Article 43 Application for centralised marketing authorisation

1. An application for a centralised marketing authorisation shall be submitted to the Agency. The application shall be accompanied by the fee payable to the Agency for the examination of the application.

2. The application for a centralised marketing authorisation of a veterinary medicinal product shall state a single name for the veterinary medicinal product to be used throughout the Union.

Article 44 Procedure for centralised marketing authorisation

1. The Agency shall assess the application referred to in Article 43. The Agency shall prepare, as an outcome of the assessment, an opinion containing the information referred to in Article 33.

2. The Agency shall issue the opinion referred to in paragraph 1 within 210 days of receipt of a valid application. Exceptionally, where a particular expertise is required, the time limit may be extended by a maximum of 90 days.

3. When an application is submitted for a marketing authorisation in respect of veterinary medicinal products of major interest, particularly from the point of view of animal health and therapeutic innovation, the applicant may request an accelerated assessment procedure. The request shall be duly substantiated. If the Agency accepts the request, the time limit of 210 days shall be reduced to 150 days.

4. The Agency shall forward the opinion to the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he or she wishes to request a re-examination of the opinion. In such a case, Article 45 shall apply.

5. Where the applicant has not provided written notice in accordance with paragraph 4, the Agency shall, without undue delay, forward its opinion to the Commission.

6. The Commission may request clarifications from the Agency as regards the content of the opinion, in which case the Agency shall provide a response to this request within 90 days.

7. The applicant shall submit to the Agency the necessary translations of the summary of product characteristics, package leaflet and labelling in accordance with Article 7, within the time limit set by the Agency, but at the latest on the date that the draft decision is forwarded to the competent authorities in accordance with paragraph 8 of this Article.

8. Within 15 days of receipt of the opinion of the Agency, the Commission shall prepare a draft decision to be taken in respect of the application. Where a draft decision envisages granting of a marketing authorisation, it shall include the opinion of the Agency prepared in accordance with paragraph 1. Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences. The Commission shall forward the draft decision to the competent authorities of Member States and to the applicant.

9. The Commission shall, by means of implementing acts, take a decision to grant or refuse a centralised marketing authorisation in accordance with this Section and on the basis of the opinion of the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

10. The Agency shall make its opinion publicly available, after deleting any commercially confidential information.

Article 45 Re-examination of the opinion of the Agency

1. Where the applicant requests a re-examination of the opinion of the Agency in accordance with Article 44(4), that applicant shall forward to the Agency detailed grounds for such request within 60 days of receipt of the opinion.

2. Within 90 days of receipt of the detailed grounds for the request, the Agency shall re-examine its opinion. The conclusions reached and the reasons for those conclusions shall be annexed to its opinion and shall form an integral part thereof.

3. Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the Commission and the applicant.

4. Subsequent to the procedure set out in paragraph 3 of this Article, Article 44(6) to (10) shall apply.