The DMF will be submitted to the FDA and to the European Health Agencies. Hovione will apply for the Certificate of Suitability (CoS) of the European Directorate Quality of Medicines (EDQM). Hovione target for the DMF submission is May 2003.

Regulatory Support
The Regulatory Affairs Department of Hovione is located in Hovione facilities in Portugal and it is responsible for all regulatory matters  of Hovione group.

The Regulatory Affairs have experience in API registration worldwide and are thus aware of the specific requirements of each National Health Authority. They provide regulatory support to our customers' ANADAs, NADAs in United States or Marketing Authorization Applications in Europe. They compile and assess API documentation /studies against the current regulatory requirements and reply expeditiously to questions that Health Authorities may put in respect to a particular Drug Application.

During the post approval phase the regulatory group inform the customers about the major changes that occur to the manufacturing process and quality control of the API. The regulatory assessment of major change is carried out in cooperation with the customer.

The non-confidential information of the DMF (Applicant’s part) will be provided after signature of the Confidential Disclosure Agreement. This documentation consists of the information required for registration excluding the confidential details of the manufacturing process and raw materials specification.

Simvastatin DMF Content - This information is confidential.
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Please click here to view the DMF Content if you have already registered with Hovione.