Variations to national authorisations

1. Where do I send the Product information texts?

To ensure a simplified and uncomplicated communication between authorities and companies the entire text communication should be done via eService.

2. How much time is provided to respond to a letter of deficiency for a Type IA Variation? What is the procedure if the response is also incomplete?

If not all required documents, according to Classification Guideline, are enclosed, they will be requested by the Austrian competent authority.

Since these deficiencies are seen as “accidental incompleteness”, the completion of the submission should be done within 4 days.

If the submission is still not complete or incorrect, it will be rejected according to AVG (Austrian “allgemeines Verwaltungsverfahrensgesetz”) (see Q4 of EMA Q&A's).

3. How to classify changes in the pharmacovigilance system?

for authorised human medicinal products: Within the scope of Change of Ownership or when introducing a new summary of pharmacovigilance system, the summary must be submitted classified as a C.I.8.a variation. Later changes to QPPV or location of the PSMF are handled via the Article 57 database.

for authorised veterinary medicinal products: Within the scope of Change of Ownership or when introducing a new DDPS, the DDPS must be submitted classified as a C.II.7 variation. Other changes, e.g. change of QPPV, fall in the respective subcategory of variation C.I.9.

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