Article 13f: Human influenza vaccines

Location:
Chapter IIA
Source:
Eur-Lex
1.   By way of derogation from Article 13c, the procedure laid down in paragraphs 2 to 4 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 to the competent authority an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid application.

3.   The competent authority shall assess the application submitted. Where deemed necessary, the competent authority may request additional data to the holder in order to complete its assessment.
4.   The competent authority shall adopt a decision within 45 days from the receipt of a valid application and shall take the measures provided for in Article 13e.

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.