Commission Regulation (EC) No 1234/2008Show full title

SECTION 1 U.K. Special procedures

Article 19 U.K. Extensions of marketing authorisations

1. An application for an extension of a marketing authorisation shall be evaluated in accordance with the same procedure as for the initial marketing authorisation to which it relates.

2. An extension shall either be granted a marketing authorisation in accordance with the same procedure as for the granting of the initial marketing authorisation to which it relates or be included in that marketing authorisation.

Article 20 U.K. Worksharing procedure

[F1 1. By way of derogation from Articles 7(1), 9, 10, 13b, 13c, 13d, 15 and 16 the holder of a marketing authorisation may choose to follow the worksharing procedure laid down in paragraphs 3 to 9 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.]

[F1 2. For the purposes of this Article, ‘ reference authority ’ shall mean one of the following:

(a) the Agency where at least one of the marketing authorisations referred to paragraph 1 is a centralised marketing authorisation;

(b) the competent authority of a Member State concerned chosen by the coordination group, taking into account a recommendation of the holder, in the other cases.]

[F1 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.

[F1 4. The reference authority shall issue an opinion on a valid application as referred to in paragraph 3 within one of the following periods:

(a) a period of 60 days following acknowledgement of receipt of a valid application in the case of minor variations of type IB or major variations of type II;

(b) a period of 90 days following acknowledgement of receipt of a valid application in the case of variations listed in Part 2 of Annex V.

5. The reference authority may reduce the period referred to in point (a) of paragraph 4, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 7(2)(c) or Article 13d(2)(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;

(c) the reference authority may extend the period referred to in point (a) of paragraph 4.

[F1 7. Where the reference authority is the Agency, Article 9(1) and (2) and Article 34(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 applicant and the Member States, together with the assessment report. Where the outcome of the assessment is favourable and the variation affects the terms of the 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 referred 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 foreseen in Article 23(1a), amend the decision(s) accordingly, provided that the revised versions of the documents referred to in Article 9(4) or Article 34(4) of Regulation (EC) No 726/2004 have been received. The Community Register of Medicinal Products provided for in Article 13(1) and Article 38(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.

[F2 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.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

F2 Inserted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

Article 21 U.K. Pandemic situation with respect to human influenza

[F1 1. By way of derogation from Chapters I, II, IIa and III, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation or by the Union in the framework of Decision 2119/98/EC of the European Parliament and of the Council (1) , the relevant authorities or, in the case of centralised marketing authorisations, the Commission may exceptionally and temporarily accept a variation to the terms of a marketing authorisation for a human influenza vaccine, where certain non-clinical or clinical data are missing.]

2. Where a variation is accepted pursuant to paragraph 1, the holder shall submit the missing non-clinical and clinical data within a time limit set by the relevant authority.

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

Article 22 U.K. Urgent safety restrictions

[F1 1. Where, in the event of a risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, the holder takes urgent safety restrictions on its own initiative, it shall forthwith inform all relevant authorities and, in the case of a centralised marketing authorisation, the Agency.

If the relevant authority or, in the case of a centralised marketing authorisation, the Agency has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions shall be deemed accepted.]

2. In the event of a risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, relevant authorities or, in the case of centralised marketing authorisations, the Commission may impose urgent safety restrictions on the holder.

3. Where an urgent safety restriction is taken by the holder or imposed by a relevant authority or the Commission, the holder shall submit the corresponding application for variation within 15 days following the initiation of that restriction.

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

(1)

[F1 OJ L 268, 3.10.1998, p. 1 .]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).