Run a retail pharmacy or optical business

Selling medicines and optical appliances sits at the boundary of retail and healthcare. The thresholds matter: any retailer can sell general-sale medicines within pack-size limits, but Pharmacy (P) and Prescription Only (POM) medicines need registered pharmacy premises, and sight tests and contact lens fitting need registered professionals.

Register your pharmacy premises

Pharmacy Registration

Pharmacy Registration - Sale of medicines (pharmacy)

Regulator: Gphc
Typical fee: £416 annual premises renewal; £1,088 total for a new premises registration
Timeline: 12 weeks for new registrations
Frequency: annual
Legal basis: Medicines Act 1968; Human Medicines Regulations 2012

Required for retail pharmacy premises in Great Britain. Must register with the General Pharmaceutical Council (GPhC); pharmacies in Northern Ireland register with the Pharmaceutical Society of Northern Ireland instead. Company-owned (body corporate) pharmacies must have a superintendent pharmacist. GPhC inspections are risk-based and intelligence-led rather than on a fixed annual cycle. Must comply with professional standards. A Responsible Pharmacist must be in charge whenever the pharmacy is open, with a notice displaying their name.

Have a responsible pharmacist in charge

Handle controlled drugs correctly

Registered community pharmacies generally operate under the general authority in the misuse of drugs legislation rather than individual Home Office licences — but record-keeping and safe custody duties are strict.

Home Office Controlled Drugs Licence

Home Office Controlled Drugs Licence - Controlled drugs (pharmacy)

Regulator: Home Office
Typical fee: No fee for most healthcare providers
Timeline: 6-8 weeks
Frequency: one time
Legal basis: Misuse of Drugs Act 1971; Misuse of Drugs Regulations 2001

Most healthcare providers (hospitals, care homes, pharmacies) operate under general authority and do not need individual licences. Licence required for holding large quantities of controlled drugs not for immediate dispensing, or for importing/exporting. Accountable Officer must be appointed. Strict record-keeping and safe custody requirements under Controlled Drugs (Supervision of Management and Use) Regulations 2013.

Optical goods and General Optical Council duties

General Optical Council registration

Registration duties for businesses selling optical appliances (spectacles and contact lenses) under the Opticians Act 1989 — registration with the General Optical Council and sight tests by registered optometrists.

If you sell optical appliances or run an opticians, the Opticians Act 1989 regulates who may carry on the business. A body corporate carrying on business as an optician must be registered with the General Optical Council (GOC) and meet the conditions in the Act, and the sale of spectacles and contact lenses is restricted — generally they may only be sold by or under the supervision of a registered optometrist or dispensing optician. Sight tests must be carried out by a registered optometrist (or registered medical practitioner). Practitioners themselves must be registered with the GOC.

Statutory source: Opticians Act 1989 (c.44)
Regulator: General Optical Council (GOC)
Core duties: Register the body corporate with the GOC where required; ensure spectacles and contact lenses are sold only by or under the supervision of a registered optician; ensure sight tests are carried out by a registered optometrist or medical practitioner; use only GOC-registered practitioners
Territorial scope: United Kingdom
Consequence of breach: Selling optical appliances or carrying on an opticians business in breach of the Act is an offence; the GOC can refuse, suspend or erase registration and take enforcement action

General-sale medicines for ordinary retailers

You do not need to be a pharmacy to sell paracetamol or antacids — but the limits are tight and the pack sizes matter.

No Licence Required (retail sale)

No Licence Required (retail sale) - Sale of general sale list (GSL) medicines

Regulator: Mhra
Typical fee: None
Frequency: ongoing
Legal basis: Human Medicines Regulations 2012

General retailers (supermarkets, etc.) can sell General Sale List medicines without pharmacy registration. Includes common medicines like paracetamol, aspirin, antacids. Must be sold in manufacturer's original packaging. Pack size limits apply — paracetamol may only be sold in packs of up to 16 tablets by general retailers (packs of up to 32 are Pharmacy medicines), and you should not sell more than 100 tablets in one transaction. Must display away from baby food. Cannot sell Pharmacy (P) or Prescription Only (POM) medicines.

Where these rules apply

The GPhC regulates pharmacy premises in Great Britain — pharmacies in Northern Ireland register with the Pharmaceutical Society of Northern Ireland instead. The General Optical Council and the medicines framework under the Human Medicines Regulations 2012 are UK-wide. The retail spine — consumer rights, pricing, data protection — applies to the shop side of both professions; pharmacies are also exempt from Sunday trading size restrictions in England and Wales when selling only medicinal products and medical and surgical appliances.

Official sources

The regulators for pharmacy and optical retail.

Pharmacy Order 2010 (the GPhC registration framework) (opens in a new tab) legislation.gov.uk
General Optical Council (opens in a new tab) GOC
MHRA — medicines and healthcare products regulation (opens in a new tab) GOV.UK

Run a retail pharmacy or optical business

Medicines and controlled drugs compliance

Running clinical trials in the UK

MHRA authorisation for medicines and medical devices

MHRA licensing for medicines and medical devices

Pharmaceutical manufacturer: compliance checklist

Register your pharmacy premises

Have a responsible pharmacist in charge

Handle controlled drugs correctly

Optical goods and General Optical Council duties

General-sale medicines for ordinary retailers

Where these rules apply

Official sources

Related guides in General Compliance

Register your pharmacy premises

Have a responsible pharmacist in charge

Handle controlled drugs correctly

Optical goods and General Optical Council duties

General-sale medicines for ordinary retailers

Where these rules apply

Official sources