The Medicines Act 1968

The legal requirements that apply to the sale, supply, dispensing and labelling of each class are dealt with separately below. Meaning of “retail sale” and “wholesale dealing” The selling of a medicinal product constitutes “wholesale dealing” if it is sold to a person for the purpose of: (a) selling or supplying it, or (b) administering it, or causing it to be administered to one or more human beings, the sale, supply or administration being in the course of a business carried on by the purchaser. Any sale that does not fall within this definition of “wholesale dealing” is a retail sale. The restrictions on the retail sale of medicinal products also apply to supply and to supplying “in circumstances corresponding to retail sale”, which includes the dispensing of prescriptions under the Health Service.

There are three categories of medicine:

Prescription-only medicines (POM), which may be sold by a pharmacist if they are prescribed by a prescriber

A PO medicine is a product that is licensed as a GSL medicine, but is restricted to sale through pharmacies only. PO medicines do not need to be sold under the supervision of a pharmacist. These medicines may be available for self-selection by members of the public.

Prescription Only Medicines are those medicinal products described as such in the Prescription Only Order. The main classes of Prescription Only Medicines are as follows:

• medicinal products which a marketing authorisation has been granted and in the marketing authorisation are classified as being prescription only medicines.
• medicinal products which no marketing authorisation has been granted consisting of, or containing a specific substance
• medicinal products that are for parenteral administration
• medicinal products that are Controlled Drugs unless a marketing authorisation has been granted in respect of that medicinal product whereby the product is classified as being a Pharmacy or General Sale List Medicine; cyanogenic substances, other than preparations for external use
• medicinal products that on administration emit radiation or generate any substance that emits radiation, in order that radiation may be used
• medicinal products in respect of which marketing authorisation has been granted consisting of, or containing, aloxiprin, aspirin, or paracetamol in the form of non-effervescent tablets or capsules that are classified as being pharmacy only or general sale list medicines.
• Medicinal products in respect of which a marketing authorisation has been granted consisting of or containing pseudoephedrine salts or ephedrine base or salts in all pharmaceutical forms which in the market

Pharmacy medicines (P), which may be sold by a pharmacist without a prescription

A Pharmacy medicine means a medicinal product that is not a Prescription Only Medicine and is either:

• Not a medicinal product on a General Sale List

• Products for human use containing aloxiprin, aspirin, paracetamol or salicylamide that are offered or exposed for sale by retail in packs which do not contain aspirin, or where the amount of aspirin in each tablet does not exceed 325 milligrams, more than 30 tablets

• Where the amount of aspirin in each tablet exceeds 325 milligrams, but does not exceed 500 milligrams in more than 20 tablets;

• In the case of tablets that are not effervescent, where they are enteric coated tablets, containing more than 75mg aspirin only, more than 28 tablets, or where they contain aloxiprin or paracetamol or a combination of any or all of these substances, more than 16 tablets;

• in the case of powder or granules, more than 10 sachets;

• in the case of capsules, where they contain aloxiprin, aspirin or paracetamol or a combination of any or all of those substances, more than 16 capsules;

• in the case of liquid preparations of paracetamol, intended for persons aged 12 years and over, more than 160 ml, intended for persons less than 12 years, individual doses of more than 5 ml each, or more than 20 unit doses;

• Tablets for human use containing bisacodyl that are offered or exposed for sale by retail in containers or packages containing more than 40 tablets;

1. products for human use containing ibuprofen that are offered or exposed for sale by retail in containers or packages containing:
2. in the case of tablets, more than 16 tablets;
3. in the case of capsules, more than 16 capsules;
4. in the case of powders or granules, more than 12 sachets; iv in the case of a product for topical use, more than 2.5g of ibuprofen; 18 19
5. in the case of liquid preparations, unit doses of more than 5mls each, or more than 20 unit doses.
6. products for topical human use containing clotrimazole that are offered or exposed for sale by retail in containers or packages containing more than 500 milligrams of clotrimazole;
7. products for human use containing sodium picosulphate in a container or package of more than 60 ml of the product
8. products for human use containing loperamide hydrochloride in a container or package of more than 6 tablets or capsules;
9. Omeprazole 10mg;
10. Statins – simvastatin 10mg;
11. Products for human use containing ranitidine hydrochloride in a container or package of more than 12 tablets;
12. products for human use containing famotidine in a container or package of more than 12 tablets;
13. products for human use containing heparinoid in a container or package of more than 20g of the product;
14. Products for human use containing ibuprofen lysine in a container or package containing more than 16 tablets

General sales list (GSL) medicines, which may be sold without a prescription in any shop.

Part of the GSL order specifies certain classes of medicinal products for human use that shall not be available on general sale. They are medicinal products promoted, recommended or marketed:

• for use as anthelmintics,

• for parenteral administration,

• for use as eye drops,

• for use as eye ointments,

• for use as enemas,

• for use wholly or mainly for irrigation of wounds or of the bladder, vagina or rectum,
• for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

All General Sale List medicines, except those that have been designated as foods or cosmetics, must be licensed products (it should be noted that a medicinal product, made up in a pharmacy for sale from that pharmacy without a marketing authorisation, is classified as a Pharmacy medicine even though all its ingredients are in the GSL Order).

Medicinal products that are for sale or supply either for oral administration as a food or for external use as a cosmetic are General Sale List medicines. This does not

include products that are Prescription Only Medicines, eye drops or eye ointments, or any product that contains either: (a) vitamin A, vitamin A acetate or vitamin A palmitate with a maximum daily dose equivalent to more than 7,500 international units of vitamin A or 2,250 micrograms of retinol; (b) vitamin D with a maximum daily dose of more than 400 units of antirachitic activity.