Manufacturers of medicinal products and their premises must be licensed. Medicinal products must not be put on the market unless they have a market authorization. A manufacturer must obtain authorisation from the Medicines and Healthcare Products Regulatory Authority or an equivalent EU state body. The Authority must be satisfied the product is suitable for public use. Each product is categorised as prescription only, pharmacy sale only or general sale.
Licensed medicinal products for human use must comply with certain guidelines. It is required that certain evidence is retained so as to prove compliance. Advertisements of medicines must be retained The Medical and Healthcare Products Regulatory have powers of monitoring and enforcement.
Records must be kept of details of manufacture and assembly of each batch and showing that tests have been carried out. Records must be kept for five years or one year after the expiry of the date of the batch whichever is longer. Samples of the pack must be kept one year after the expiry date. There must be a system of recording and reviewing complaints and a system for recalling products.
Wholesalers and Importers
Wholesalers and importers of medicines must generally be licensed. A purchaser of medicines from other EU countries must have a Wholesale Dealers Licence in the UK. Illicit Drugs and controlled substances require consent from the Home Office.
Wholesale medicinal sales must only be made to certain parties such as retail pharmacists, registered medical practitioners, the NHS etc. It is not permitted to sell medicines wholesale to doctors and pharmacists or other persons unless product licences or an equivalent EU authorization is held.
There are common EU requirements in relation to most medical products. Imported medicines or medical devices may only be sold if they meet EU requirements. Medicines already licensed in other EU states require a UK license, but can be licensed under a simpler licensing scheme. Where goods are imported from outside the EU, there is a more onerous licensing and approval process.
A business importing medicinal products into the UK must maintain records and samples. Importers of such products must give undertakings on behalf of the manufacturer that they will maintain adequate staff, premises and facilities, provide and maintain a designated quality control, system, ensure standards of strength quality and purity applicable under the relevant product licence and carry out tests of strength, quality and purity.
Medicines can be obtained in three ways:
- From a retail outlet such as a supermarket with no input from a health professional at the point of sale.
- From a pharmacy, where the product can only be sold under the supervision of a pharmacist who will advise the patient on how to use the medicine.
- On prescription, following consultation with a doctor and the pharmacist at the point of dispensing.
A retail pharmacy premises must be registered with the Royal Pharmaceutical Society of Great Britain. The General Pharmaceutical Council is due to take over from the Royal Pharmaceutical Society of Great Britain as regulator in the near future. It may only sell prescription medicines under the supervision of a pharmacist. The sale of such medicines must be based on a written prescription. There are provisions for inspections and professional practice obligations.
The advertising of medicines is controlled by regulations enforced by the MHRA and self-regulation through Codes of Practice for the pharmaceutical industry, administered by trade associations. The MHRA has a duty to consider breaches of regulations on the promotion of medicines. Its function is to protect public health by promoting the safe use of medicines, ensuring that they are honestly promoted as to their benefits, uses and effects, in compliance with current legislation.
The Regulations provide requirements for advertising to the public and advertising to health professionals. Advertising to the public is permitted for medicines legally classified for pharmacy sale or general sale list. The Regulations prohibit the issue of any advertisement to the general public which is likely to lead to the use of a prescription only medicine. Advertising issues are, in the majority of cases resolved administratively, with prosecution reserved for serious cases, for example, where there is a safety issue or a company is uncooperative or repeatedly offends.
Labels and Information
Information on how a medicine should be used is provided to doctors and pharmacists in the Summary of Product Characteristics. Information to patients or consumers is provided on the label and by patient information leaflets, unless all the necessary information can be included on the label.
Patient information must be written in clear and understandable terms. New requirements have recently been introduced requiring those responsible for the writing of statutory patient information leaflets to make sure that these have been drawn up to take into account the needs and views of patients.
Herbal medicinal products must be registered and licensed. This is required for manufacturers, importers and wholesalers. Licensing is under the Traditional Herbal Medicines Registration Schem .
Herbal medicinal products must be registered before they can be put on the market. It is not permissible to sell supply, make or possessed traditional herbal products if they have been placed on the market by someone without registration or it is believed they will not comply with conditions. Those selling or supplying herbal medicinal product must keep certain records in relation to origin.
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