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AN ACT to amend the Food a d Drugs Act, Chapter 291 of the Substantive Laws of Belize, Revised Edition 2011, to make provision empowering the making of regulations to empower to the establishment of a drug registry as well as generally to give effect to the provisions of the Act, to make Further provisions regarding the labelling of food or drug products; and
to provide for matter connected therewith or incidental thereto.

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REGULATIONS made by the Minister responsible for health in the exercise of the powers conferred upon him by
section 55 of the Food and Drugs Act, Chapter 291 of the Substantive Laws of Belize, Revised Edition 2011 and all other powers thereunto him enabling.

This guideline describes the following points;

  • PART I Preliminary
  • PART 2 Registration and Licensing of Drugs
  • PART 3 Facility Licence
  • PART 4 Miscellaneous

 

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The quality of herbal substances, herbal preparations and herbal medicinal products are determined by the quality of the starting plant material, development, in-process controls, GMP controls, and process validation, and by specifications applied to them throughout development and manufacture. This guideline addresses specifications, i.e., those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life. Specifications are an important component of quality assurance but are not its only component. All of the considerations listed above are necessary to ensure consistent production of herbal substances/preparations and herbal medicinal products of high quality.

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In order to ensure appropriate and consistent quality of medicinal plant/herbal substances .it is necessary to establish good agricultural and collection practice for herbal starting materials (GACP). The concept of Good Manufacturing Practice for the manufacture, processing, packaging and storage of Active Pharmaceutical Ingredients (APIs) also applies to medicinal
plants/herbal substances.

This document is intended to address the specific concerns of growing, collecting and primary processing of medicinal plants/herbal substances that are used for medicinal purposes. It addresses specific issues associated with agricultural production and collection of medicinal plants/herbal substances in the wild. These considerations should be read in connection with GMP guidelines for APIs and should apply to all methods of production including organic production in accordance with regional and/or national regulations.

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This guideline provides advice on the viral safety data and documentation that should be submitted in a request for authorisation of a clinical trial of a human biotechnological medicinal product. The guideline provides for a harmonised approach throughout the European Union, for both sponsors and regulators, with regard to the assessment of viral safety of biotechnological IMPs during clinical development. This will be especially beneficial for multi-centre studies, potentially involving several different member states.

This guideline applies to human biotechnological IMPs prepared from cells cultivated in vitro from characterised cell banks of human or animal origin as described in Q5A. Many IMPs are derived from well-characterised rodent cell lines such as CHO, NS0 or SP2/0, although a variety of other cell lines are in use and under development and should be considered on a case-by-case basis.

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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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