Article 20: Worksharing procedure

Location:

Chapter IV, section 1

Source:

1. By way of derogation from Articles 7(1) and Articles 9, 10, 13b, 13c, 13d, 15 and 16 the holder shall follow the worksharing procedure laid down in paragraphs 3 to 9 of this Article in the following cases:

(a) for marketing authorisations referred to in Chapters II and III, where a minor variation of type IB, a major variation of type II, or a group of variations as provided for in Article 7(2)(b) or (c) that does not contain any extension relates to several marketing authorisations owned by the same holder;

(b) for purely national marketing authorisations referred to in Chapter IIa, where a minor variation of type IB, a major variation of type II, or a group of variations as provided for in Article 13d(2)(b) or (c) that does not contain any extension relates to several marketing authorisations owned by the same holder;

(c) for purely national marketing authorisations referred to in Chapter IIa, where a minor variation of type IB, a major variation of type II, or a group of variations as provided for in Article 13d(2)(b) or (c) that does not contain any extension relates to one marketing authorisation that is owned by the same holder in more than one Member State.

Variations covered under (a), (b) or (c) may be subject to the same worksharing procedure.

The reference authority or, in the case of purely national marketing authorisations, the competent authority may refuse to process a submission under the worksharing procedure where the same change(s) to different marketing authorisations require the submission of individual supportive data for each medicinal product concerned or a separate product-specific assessment.

3. The holder shall submit to all relevant authorities an application containing the elements listed in Annex IV, with an indication of the preferred reference authority.

The coordination group shall choose a reference authority. If the application fulfils the requirements laid down in the first subparagraph, that reference authority shall acknowledge receipt of a valid application.

Where the chosen reference authority is the competent authority of a Member State which has not granted a marketing authorisation for all the medicinal products affected by the application, the coordination group may request another relevant authority to assist the reference authority in the evaluation of that application.

4. The reference authority shall issue an opinion on a valid application as referred to in paragraph 3 within a period that corresponds to the assessment period of the highest type of variation included following acknowledgement of receipt of a valid application in the case of minor variations of type IB or major variations of type II.

5. The reference authority may reduce the period referred to in paragraph 4, having regard to the urgency of the matter, or may extend it to 90 days for variations listed in Annex V or for grouping of variations in accordance with Article 7(2), first subparagraph, point (c), or Article 13d(2), first subparagraph, point (c).

6. Within the period referred to in paragraph 4, the reference authority may request the holder to provide supplementary information within a time limit set by the reference authority. In this case:

(a) the reference authority shall inform the other relevant authorities of its request for supplementary information;

(b) the procedure shall be suspended until such supplementary information has been provided;

7. Where the reference authority is the Agency, Article 9(1) and (2) of Regulation (EC) No 726/2004 shall apply to the opinion referred to in paragraph 4.

The Agency’s opinion on the application shall be transmitted to the holder and the Member States, together with the assessment report. Where the outcome of the assessment is favourable and the variation affects the terms of a Commission decision granting the marketing authorisation, the Agency shall also transmit to the Commission its opinion and the grounds for its opinion as well as the revised versions of the documents set out in Article 9(4) of Regulation (EC) No 726/2004.

Where the Agency issues a favourable opinion, the following shall apply:

(a) if the opinion recommends the variation to the terms of a Commission decision granting the marketing authorisation, the Commission shall, having regard to the final opinion and within the time limits provided for in Article 23(1a), amend the decision accordingly, provided that the revised versions of the documents set out in Article 9(4) of Regulation (EC) No 726/2004 have been received. The Union Register of Medicinal Products provided for in Article 13(1) of Regulation (EC) No 726/2004 shall be updated accordingly;

(b) the Member States concerned shall, within 60 days following receipt of the final opinion of the Agency, approve that final opinion, inform the Agency thereof and, where necessary, amend the marketing authorisations concerned accordingly, provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned.

8. Where the reference authority is the competent authority of a Member State:

(a) it shall send its opinion to the holder and to all relevant authorities;

(b) without prejudice to Article 13 and within 30 days following receipt of the opinion, the relevant authorities shall approve that opinion and inform the reference authority;

(c) the concerned marketing authorisations shall be amended accordingly within 30 days following the approval of the opinion, provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned.

9. Upon request from the reference authority, the Member States concerned shall provide information related to the marketing authorisations affected by the variation for the purpose of verifying the validity of the application and of issuing the opinion on the valid application.

10. Where harmonisation of a section of the summary of product characteristics of a purely national marketing authorisation has been achieved through a worksharing procedure, any subsequent variation submission affecting the harmonised section shall be transmitted simultaneously to all Member States concerned.

11. In justified cases, in accordance with the guidelines referred to in Article 4(1), when agreed by the competent authorities of the Member States and the Agency, the holder may choose to follow the worksharing procedure laid down in paragraphs 3 to 9 for the marketing authorisations referred to in Chapters II, IIa and III, where a minor variation of type IB, a major variation of type II, or a group of variations where at least one of the variations is a minor variation of type IB or a major variation of type II that does not contain any extension, relates to several marketing authorisations owned by several holders in more than one Member State.