Medicines
Medicines are subject to high regulatory requirements in terms of their development, manufacture, price, marketing, advertising, etc.
Every Medicinal Product must demonstrate its quality, safety and efficacy to the Health Authorities Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and European Medicines Agency (EMA) in order to obtain a Marketing Authorization that must be renewed after 5 years. Any changes to the medicinal product after authorization must also be notified.
At Supplaffairs, we usher the product throughout its life cycle: the Marketing Authorization application, the registration of variations, the five-year revalidation, preparation of the technical data sheet, package leaflet, labeling, price and financing request, advertising authorization, import-export, etc.
We also provide technical and scientific advice to pharmaceutical laboratories on the regulations that apply to quality standards, on preclinical and clinical studies, GMP (Good Manufacturing Practices) and Pharmacovigilance.
In addition, we have a deep knowledge of medicinal plants, the basis of the so-called traditional herbal medicinal products (THMPs), which gives us an added value when registering this type of medicines.
Services we offer
- Medicinal products registration (Innovative medicinal products, Generic medicinal products, Biological medicinal products, Tradicional Herbal Medicinal Products, Homeopathic medicines, Medical gases, Radiopharmaceuticals).
- Preparation of the Registration Dossier
- Preparation of the Electronic Application Form (E-Af)
- Preparation of Electronic Files: eCTD (Electronic Common Technical Document) and Nees (Non-eCTD Electronic Submissions).
- Labeling of Medicines and Telematic Management of Technical Data Sheets and Leaflets
- Application for Marketing Authorization
- National Procedure
- Decentralized Procedure
- Mutual Recognition Procedure
- Centralized Procedure
- Register Variations
- Five-year Renovation
- Cancellation of a Marketing Authorization
- Temporary Suspension
- Marketing Authorization Notifications
- Pharmaceutical Products Certificate Applications
- Export and import of medicines
- Drug pricing and financing procedure
- Advertising authorization request
