Medicines Licensing in the UK

What is the role of the Medicines and Healthcare products Regulatory Agency (MHRA)?

• To manufacture medicinal products

• To provide marketing authorisations

• To distribute medicines

• To conduct clinical trials

What does Marketing Authorisation (MA) allow?

• Manufacture of herbal medicines

• Advertising of medicinal products

• Sale, supply, import, and export of a medicinal product

• Clinical trials without restrictions

What is required for a product to be classified as a herbal medicinal product?

• It must include a treatment purpose for an illness

• It must be processed from plant materials

• It must contain multiple active ingredients

• It must have a Marketing Authorisation

Answer explanation

Traditional Herbal Medicinal Product (with Traditional Herbal Registration - THR)

What is the purpose of the Traditional Herbal Medicinal Registration Scheme?

• To ensure safety and quality of herbal medicines

• To license all herbal products

• To promote herbal medicines in advertising

• To provide marketing authorisations for all herbal products

What is the purpose of the Early Access to Medicines Scheme (EAMS)?

• To provide access to unlicensed medicines for patients with serious conditions

• To allow advertising of new medicines

• To simplify the licensing process for all medicines

• To ensure all medicines are available without restrictions

What is a Clinical Trial Authorisation (CTA)?

• A license for manufacturing medicines

• A license for marketing herbal products

• A license for wholesale distribution

• A license for conducting clinical trials

What does a Manufacturer’s Licence (ML) authorize?

• The sale of herbal remedies

• The manufacture of medicinal products

• The distribution of unlicensed products

• The import of medicines from abroad

What is the classification of a medicine that requires a prescription?

• Prescription Only Medicine (POM)

• Pharmacy Only Medicine (P)

• Over-the-Counter (OTC)

• General Sales List (GSL)

What does the term 'wholesale dealing' refer to?

• Distribution of herbal remedies

• Manufacturing of medicinal products

• Sale of a medicinal product to a business for resale

• Sale of a medicinal product to a consumer

What is the main focus of pharmacovigilance?

• Conducting clinical trials

• Licensing herbal products

• Monitoring safety of medicinal products

• Promoting new medicines