General Sale Medicines (GSL)

• General Sale Medicines (GSL) are being covered in the MPharm Programme.

Human Medicines Regulations 2012

• Chapter 2 governs dealings in medicinal products.
• Regulation 220 expresses the principle that medicinal products can be sold or supplied in retail settings only from registered pharmacies.
• There is an exception for products classified as general sale items.

Classes of Medicinal Products

• The UK has three legal classifications for medicinal products: General Sale Medicines (GSL), Pharmacy Medicines (P), and Prescription-Only Medicines (POM).
• Pharmacy Only (PO) medicines are legally GSL medicines but their sale is restricted to pharmacies by the manufacturer.
• PO is not a legal classification.
• Over the counter (OTC) is a term for medicines available without prescription, i.e., GSL and P.
• Controlled drugs are within legal classifications: POM or P.

Medicines Switching Classes

• The MHRA may re-classify medicine, thus moving classifications.
• The usual move is from POM -> P -> GSL.
• Restrictions on sales depend on indication, pack size, strength, and route of administration.
• Wider patient access to meds is a result of the changes.
• There is an increased role for pharmacists' expertise.
• The government wants to declassify medicines for self-care and to save NHS costs
• Recent POM to P switches include fexofenadine, desogestrel, topical vaginal oestrogen, and tadalafil.
• The pharmacy profession typically does not like medicine switches from P to GSL.
• GSL medicines may rarely move to P or POM due to manufacturer decisions.

General Sales Medicines

• GSL is more commonly known as General Sales List.
• The list is no longer used.
• The HMR 2012 defines a GSL medicine as a product which is not POM or P.
• GSLs has a marketing authorisation to be available via general sale
• There are medicines can be sold or supplied with reasonable safety in non-pharmacy, non-pharmacist supervised premises.
• GSL medicines may only be GSL in smaller packs
• GSLs may be specific for certain indications or forms.

Retail Sale of GSL Medicines (1)

• GSL can be sold at a registered pharmacy or other settings if requirements are met.
• Premises need to be able to be closed to exclude the public.
• The product must have been made up for sale in a container.
• The product must not have been opened since.
• Schedule 15 requirements must be followed where applicable.
• GSL medicines may be sold from vending machines with occupier premises.
• They need to be able to close so as to exclude the public.
• If selling in a pharmacy, a 'responsible pharmacist' must sign in/assume role.
• Exception for emergencies; supply is possible in the event or anticipation of a pandemic disease.

Retail Sale of GSL Medicines (2)

• Airplanes and trains can sell GSLs.
• Sale managed by operator/commander (airplane) or operator of train.
• Medicines must have been made up for sale/supply elsewhere.
• Items should be stored to exclude public

Products To Note

• Products above a specified maximum daily dose of vitamin A/D cannot be GSL
• Eye ointments/ Anthelmintics/ enemas are never available on GSL
• Products designated for parenteral administration.
• Products used mainly for bladder irrigation/vagina/rectum cannot be GSL.
• Preparations containing aloxiprin or asprin for children cannot be GLS.
• The marketing classification determines whether a product could instead be GSL.