API (Active Pharmaceutical Ingredient)

API (Active Pharmaceutical Ingredient): The biologically active component in a pharmaceutical drug responsible for its therapeutic effect.

API Legislation in the United Kingdom:

  1. UK Good Manufacturing Practice (UK GMP) – Ensures APIs are manufactured to the highest standards of quality and safety, reflecting EU guidelines before Brexit.

  2. The Human Medicines Regulations 2012 (as amended) – Governs the manufacture, distribution, and importation of medicinal products, including APIs.

  3. The Medicines and Healthcare Products Regulatory Agency (MHRA) – Enforces Good Manufacturing Practice (GMP) for API manufacturers in the UK, ensuring compliance with EU standards.

  4. The Control of Substances Hazardous to Health (COSHH) Regulations 2002 – Relates to the safe handling of hazardous materials, including certain APIs.

  5. The UK Medicines Act 1968 – Establishes provisions for the regulation of pharmaceutical products, including APIs.

API Legislation in the European Union:

  1. EU GMP Guidelines – The European Union’s Good Manufacturing Practice guidelines provide detailed rules for API manufacturing, including the supply chain and distribution.

  2. Directive 2001/83/EC (as amended) – The main EU legislation regulating medicinal products for human use, including API requirements for quality, manufacturing, and testing.

  3. European Medicines Agency (EMA) – Provides guidelines on the manufacture and quality control of APIs, including GMP for APIs.

  4. Directive 2011/62/EU – Combats counterfeit medicines, establishing stricter guidelines for API sourcing and supply chains.

  5. Regulation (EC) No 726/2004 – Establishes the European Medicines Agency (EMA) and regulates the authorization of medicines, including APIs.

  6. EU Regulation (EC) No 1223/2009 on Cosmetic Products – Includes APIs used in cosmetic products, setting requirements for safety and quality.

Legislation list generated by AI.  Edited by Humans.