Medi-Regist Bt. - Regulatory affairs

Medi-Regist regulatory affairs department features expertise in the following areas:

The MRP is based on the idea that a national license approved in one EU Member State (Reference Member State - RMS) should be mutually recognised in other EU countries (Concerned Member States - CMS).

Compilation of registration dossier
Evaluation of documentation and production of deficiency lists
Application to authorities (national, MRP and DCP)
Coordination and follow-up during the registration process
Continuous contact with the respective authorities

Decentralised Procedure for human and veterinary drugs

The medicinal product has not yet received a Marketing Authorisation in any EU Member State.

National Authorization for human and veterinary allopatic, homeopatic and herbal drugs

If applicant wishes to obtain a license in one Member State (MS) an application must be made to the national Competent Authority (CA) which then issues a national Marketing Authorization (MA) license.

Life cycle management

We support you in the maintenance of your existing marketing authorizations. We prepare and submit the variations/renewals and other modifications to competent authorities on behalf of your company.

Readability Test preparation

Medical device notification

Support compilation of registration dossier according to EU requirements
Support to receive attestation and CE mark

Food supplement and Cosmetics notification

Compilation of registration dossier
Evaluation of documentation according to deficiency list
Medical writing:

Application form
Label
Translations

Submission the documentation to authority (mainly Hungarian)
Coordination and follow-up during the registration process
Continuous contact with the authority.