Our company undertakes the coordination of marketing authorization procedures in relation to national, decentralized and mutual recognition procedures as well. Our experts take care of effective communication with the staff of the competent authority(ies) and the contractual partner(s).

Our experts can assist our clients with the transfer of the marketing authorization to another marketing authorization holder, and we can also coordinate the variations of the marketing authorization concerning the related PSMF change and the possible product name change.

Electronic communication has brought about the need for foreign-based marketing authorization holders to have a local contact person designated for communication based in Hungary. As Inparibus is located in Hungary, we fulfil this requirement for our clients.

Our experts prepare the Product Information of the medicines for our clients in Hungarian (and English, if required), including the summary of product characteristics, the package leaflet and the label text.

Our experts perform dossier audits for our clients in accordance with the effective official regulations, regardless of their legal basis, in order to reveal any deficiencies. Our clients are informed of the current status of the dossier and its proposals for additions in the form of an audit report.

It is important that the packaging materials fully reflect the label text and package leaflet adopted by the competent authority. Our colleagues carry out careful inspection of packaging materials for our clients with due thoroughness.

If there is a change in the form or content of the packaging materials of the medicinal product, a final sample notification must be submitted to the local competent authority. Our colleagues ensure that when using new packaging material, the final sample is notified before it is placed on the market.

It may happen that the finished products are manufactured by using defected packaging materials which differ from approved wording of the marketing authorization. To avoid the need to repack or possibly destroy the entire batch, our experts will do their best to ensure that those formal errors which do not pose a risk to the safety of medicines are accepted by the competent authority.

If there is a disruption in the continuous supply of a medicinal product, the temporary shortage of the product must be reported to the competent authorities (pharmaceutical authority as well as reimbursement authority). Our experts will notify the competent authorities of the beginning of the product shortage and of the end of the shortage.

If our client has a EUDAMED (European Database for Medical Devices) registration, we will carry out the device registration in the NOR (National Medical Device Register) on behalf of our client to be able to distribute the device in Hungary. Our experts will help you prepare the Hungarian label and instruction for the user, as well as check the related graphic materials. We also prepare the oath translation certificate of the English master text to Hungarian for our clients.

Our experts support the development activities of our clients in the field of food supplements and foods for special medical purposes by evaluating the target composition in accordance with Hungarian and EU requirements, and we also assist with the preparation of the Hungarian label text and the verification of the related packaging materials. We compile the documentation required for the notification process for our clients (including expert opinions concerning foods for special medical purposes) and prepare and submit the notification of the distribution of the product to the competent authority.