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The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance.

This Guideline is intended to assist Applicants/MA holders in the compilation of the active substance section of their dossiers for a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV) of a medicinal product. It is also intended to help ASMF holders in the compilation of their ASMFs.

This guideline also contains the following points;

  1. Content of the Active Substance Master File
  2. Use of the Active Substance Master File Procedure
  3. Content of the MA-dossier when the Active Substance Master File Procedure is used
  4. Changes and updates to the Active Substance Master File
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The principles of this guideline should be considered during the pharmaceutical development of all paediatric medicines as proposed in marketing-authorisation applications (MAAs) or applications to extend or vary marketing authorisations to the paediatric population (MAVs). Depending on the phase of the development, the principles of this guideline should also be considered for the purpose of the paediatric investigation plan (PIP) applications. While taking into account that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, it is important to realize that this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Union.

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Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

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This document provides guidance on the clinical development strategy for a fixed combination medicinal product. The guidance applies primarily to small molecules irrespective of the route of administration and dosage form (immediate versus modified release), but the general principles also apply to biological products. The scientific principles are also applicable to a substance designed to dissociate in vivo into two or more active substances that form its principal therapeutic moieties. The guideline does not apply to a single molecule active substance that affects multiple pharmacological targets (i.e. has an affinity to multiple receptors involved in the desired therapeutic outcome).

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This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are proposed.

The principles described are in general also applicable to biological medicinal products. Where relevant, the principles of this guideline may also be applied to radiopharmaceuticals and to chemical investigational medicinal products.

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