For medicinal product we intend any substance or combination of substances presented as having properties for treating or preventing diseases in human beings. Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
In this sector Di Renzo Regulatory Affairs offers the following services.
- Consultancy activity on the current national and EU regulations and practices.
- Cooperation for marketing authorization applications for national, mutual recognition and decentralised procedures where Italy is either CMS or RMS.
- Advice and assistance with any national issues for Centralised registrations.
- Preparation of the documentation for national variations and renewals as well as giving advice on additional requirements in Italy for MRP & DCP variations, transfers of MAs and renewals.
- Advice and preliminary evaluation of documentation before submitting to AIFA or to the Ministry of Health
- Assistance throughout the entire bureaucratic process for National and EU applications up to the granting of the relative national authorization.
- Assistance with the preparation and deposit of pricing and reimbursement dossiers.
- Preparation of the products information documentation (SPC, labels and patient information leaflets) in accordance with the current laws and national requirements in Italy.
- Advice and assistance regarding additional documents required by the AIFA or by the Ministry of Health
- Translations of documents and product information for authorizations and assistance with any necessary sworn translations.
- Making the local payments to the AIFA on behalf of clients for applications
- Organise applications for various certificates (Free Sales Certificates, GMP, Certificate for Importation of dangerous substances, certificates for importation of samples for clinical studies or other uses)
- Arranging with various foreign consulates in Rome for the legalization of various certificates (Free Sales certificates etc.)
- National and European pharmacovigilance activity
- Suitability to transmit data to Eudravigilance
- Due diligence
- Assisting and organising meetings with assessors of the AIFA, the Ministry of Health and other relevant organisations from this sector.
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