BfArM - Federal Institute for Drugs and Medical Devices

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What happens if the ASMF is updated by the manufacturer of the active substance? Date: Topics: Licensing Type: FAQ

If the BfArM is supposed to consider an updated ASMF for an ongoing clinical trial, a substantial amendment must be applied for by the sponsor of the clinical trial concerned.

Please note that in connection with clinical trials only so-called …

Are separate documentations regarding the active substance (Active Substance Master Files [ASMF]) accepted in the course of authorisation procedures for clinical trials? Date: Topics: Licensing Type: FAQ

Yes, as a rule Active Substance Master Files [ASMF] are also accepted for chemically defined active substances in authorisation procedures for clinical trials.

However, as in the case of marketing authorisations for medicinal products, ASMF are not …

Can reference be made to ASMF that were already used for previous marketing authorisation procedures? Date: Topics: Licensing Type: FAQ

Yes, the BfArM collects ASMF in a central archive. Reference can be made to ASMF already used in marketing authorisation procedures.

Which particulars have to be given in the plan for shelf-life extensions? Date: Topics: Licensing Type: FAQ

Not less than the following particulars have to be included in the plan for shelf-life extensions:

(In order to make the requirements clear, selected examples of acceptable and unacceptable approaches are given. Please bear in mind that specific …

Do the regulations of the CMDh for the shortened renewal procedure also apply to purely national marketing authorisations? Date: Topics: Licensing Type: FAQ

National renewals according to § 31 Absatz 3 AMG of purely national marketing authorisations licensed on the basis of Article 10(1) of Directive 2001/83/EC (Generics) can be carried out as „shortened renewal“ in accordance with the requirements …

In which cases may a competent higher federal authority mandate a further renewal and how will this be communicated to the applicant? Date: Topics: Licensing Type: FAQ

According to Section 31 sub-section 1a AMG the competent higher federal authority may mandate a further renewal under the regulation in Section 31 sub-section 1 sentence 1 No. 3 associated with sub-Section 2 AMG in order to ensure further safe …

How should these marketing authorisations be submitted? Date: Topics: Licensing Type: FAQ

For each manufacturer of the investigational medicinal product (formulation) a copy of the manufacturing authorisation has to be submitted. Please note that the appendices of the manufacturing authorisation which contain information on …

Is it necessary to submit a copy of the manufacturing authorisation for the manufacture of the drug substance? Date: Topics: Licensing Type: FAQ

All manufacturers involved in the manufacturing process of biotechnological substances have to submit a manufacturing authorisation. Manufacturers who produce substances of chemical origin do not have to submit such a marketing authorisation.

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Is it necessary to submit manufacturing authorisations and import authorisations as accredited copies? Date: Topics: Licensing Type: FAQ

It is not necessary to submit accredited copies.

Is the shelf-life extension of an investigational medicinal product a substantial amendment? Date: Topics: Licensing Type: FAQ

In accordance with the Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials (CHMP/QWP/185401/2004 final, dated 31 March 2006) this depends on the …