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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.
Worksharing procedure
1. By way of derogation from Article 7(1) and Articles 9, 10, 15 and 16, where a minor variation of type IB, a major variation of type II or a group of variations in the cases of point (b) of Article 7(2) which does not contain any extension relates to several marketing authorisations owned by the same holder, the holder of such authorisations may follow the procedure laid down in paragraphs 3 to 9 of this Article. 2. For the purposes of paragraphs 3 to 9, ‘reference authority’ shall mean one of the following: (a) the Agency where at least one of the marketing authorisations referred to in 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. 3. The holder shall submit to all relevant authorities an application containing the elements listed in Annex IV, with an indication of the recommended reference authority. If the application fulfils the requirements laid down in the first subparagraph, the coordination group shall chose a reference authority and 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 the valid application 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. 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. 7. Where the reference authority is the Agency, Article 9(1), (2) and (3) and Article 34(1), (2) and (3) of Regulation (EC) No 726/2004 shall apply to the opinion on a valid application referred to in paragraph 4. Where the opinion on a valid application is favourable: (a) the Commission shall, within 30 days following receipt of the final opinion and on the basis of a proposal from the Agency, amend where necessary the concerned centralised marketing authorisations and update the Community Register of Medicinal Products provided for in Article 13(1) and Article 38(1) of Regulation (EC) No 726/2004 accordingly; (b) the Member States concerned shall, within 30 days following receipt of the final opinion of the Agency, approve that final opinion, inform the Agency thereof and amend where necessary the concerned marketing authorisations accordingly, unless a referral procedure in accordance with Article 35 of Directive 2001/82/EC or Article 31 of Directive 2001/83/EC is initiated within 30 days following receipt of the final opinion. 8. Where the reference authority is the competent authority of a Member State: (a) it shall send its opinion on the valid application 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, inform the reference authority and amend the concerned marketing authorisations accordingly. 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.
Pandemic situation with respect to human influenza
1. By way of derogation from Articles 12, 18 and 19, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation or by the Community in the framework of Decision 2119/98/EC of the European Parliament and of the Council ( 9 ) , 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.
Urgent safety restrictions
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 Commission. If no relevant authority or, in the case of a centralised marketing authorisation, the Commission has 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.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.