Article 12: Human influenza vaccines

Location:

Chapter II

Source:

1. By way of derogation from Article 10, the procedure laid down in paragraphs 2 to 5 shall apply to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine.

2. The holder shall submit simultaneously to all relevant authorities an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the competent authority of the reference Member State shall acknowledge receipt of a valid application and inform the holder and the other relevant authorities that the procedure starts from the date of such acknowledgement.

3. The competent authority of the reference Member State shall assess the application submitted. Where deemed necessary, the competent authority of the reference Member State may request additional data to the holder in order to complete its assessment.

4. The competent authority shall prepare a decision and an assessment report within 45 days from the receipt of a valid application.

The 45-day period referred to in the first subparagraph shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.

5. Within 12 days from the receipt of the decision and the assessment report of the competent authority of the reference Member State, the relevant authorities shall adopt a decision accordingly and inform the competent authority of the reference Member State and the holder thereof.