Variations to national authorisations
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.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.
4. Do the requirements of the Medical Device Regulation also apply to registered medicinal specialities?
Does the Medical Device Regulation (EU) 2017/745 need to be complied with, when for example, eye drops in multidose containers (bottle - dropper - cap), nasal sprays in multidose containers (bottle - spray head/actuator - cap) are newly introduced or changed for registered medicinal products?
Yes, further information can be found here: Drug-Device Combinations
5. How should changes to registered medicinal products in combination with medical devices/components be submitted?
If the packaging of a registered medicinal product is changed with regard to a medical device or medical device component (integral), this must be notified to the Federal Office for Safety in Health Care in accordance with Section 24 AMG.
The same requirement applies to a device co-packaged with the medicinal product or referenced in the product information.
Both when introducing a new medical device/component and when changing a medical device/component previously listed in the registration of the medicinal product, the relevant section in the form "Änderungen gemäß § 24 AMG idgF" must be completed. Corresponding additional information must be provided in sections 3.2 and 3.5.
Furthermore, the relevant documents must be enclosed or updated in the dossier (e.g. Module 3.2.R Medical Device, 3.2.P.7).
