Article 18: Human influenza and human coronavirus vaccines

Location:

Chapter III

Source:

1. By way of derogation from Article 16, the procedure laid down in paragraphs 2 to 6 of this Article shall apply to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza or human coronavirus vaccine.

For annual updates of human coronavirus vaccines that procedure shall only apply after a public announcement of the Agency. The announcement shall be published on the Agency’s webportal and include the timeframe for application.

2. The holder shall submit to the Agency an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid application and inform the holder that the procedure starts from the date of such acknowledgement.

3. The Agency shall assess the application submitted. Where deemed necessary, the Agency may request additional data to complete its assessment.

4. Within 55 days from the receipt of a valid application, the Agency shall adopt an opinion. The Agency’s opinion on the application shall be transmitted to the holder. Where the Agency’s opinion is favourable, 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.

5. The 55-day period referred to in paragraph 4 shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.

6. Having regard to the favourable opinion of the Agency, the Commission shall amend where necessary the decision granting the marketing authorisation. The Union Register of Medicinal Products provided for in Article 13(1) of Regulation (EC) No 726/2004 shall be updated accordingly.