GuidanceRegulated IndustriesHealthcare and Pharmaceuticals
Regulated Industries

Healthcare and Pharmaceuticals

MHRA regulations, health claims, and writing responsibly about medicines, treatments and wellness products.
6 min readReviewed January 2026Annual review
This UK-focused information is not legal advice.

Key points

  • Medicines can only make claims authorised by the MHRA (as defined in the Summary of Product Characteristics)
  • Health claims for foods require EU Register authorisation
  • Prescription-only medicines cannot be advertised to the public
  • Wellness products must distinguish between cosmetic and medical claims

What the Code says

The ProCopywriters Code of Practice states that we must “comply with all relevant advertising codes and regulations” and specifically recognises healthcare as a sector with “additional regulatory requirements.”

Healthcare copywriting involves navigating complex regulations designed to protect public health. Making unauthorised medical claims can have serious consequences — for the public and for your clients.

The regulatory framework

Healthcare advertising in the UK is regulated by multiple bodies:

  • MHRA (Medicines and Healthcare products Regulatory Agency) — regulates medicines advertising
  • ASA/CAP — advertising standards for health and beauty claims
  • PAGB (Proprietary Association of Great Britain) — code for over-the-counter (OTC) medicine promotion
  • ABPI (Association of the British Pharmaceutical Industry) — governs how prescription medicines are promoted to healthcare professionals

What counts as a “medicinal claim”?

Any claim that a product can:

  • Treat, prevent, diagnose or cure a disease
  • Restore, correct or modify physiological functions
  • Provide medical benefits

If a product makes medicinal claims, it must be licensed as a medicine. Unlicensed products cannot make such claims.

Advertising medicines

The rules for advertising medicines depend on their classification:

Prescription-only medicines (POM)

Cannot be advertised to the general public at all. Advertising is only permitted to healthcare professionals, and must comply with the ABPI Code.

Pharmacy medicines (P)

Can be advertised to the public, but only for their licensed indications (the conditions they’re officially approved to treat).

General Sales List (GSL)

Can be advertised more broadly, but still only for licensed indications and with required warnings. Products on the GSL are those that can be bought without the direct involvement of a pharmacist. 

All medicine advertising must:

  • Include the product name and active ingredient
  • State “Always read the label”
  • Encourage responsible use
  • Not suggest the medicine is a food or cosmetic
  • Not discourage people from seeing a doctor when appropriate
  • Not imply guaranteed effectiveness or absence of side effects

Unlicensed claims

If a client asks you to make claims about a medicine that are not one of its licensed indications, refuse. This is a serious regulatory breach, not a grey area.

Health claims for food

Health and nutrition claims for food products are regulated by retained EU law. Claims must be:

Authorised

Health claims must appear on the EU Register of nutrition and health claims. You can’t make up new health claims, regardless of how much evidence seems to support them.

Accurate

The product must meet the conditions of use for the claim (e.g. contain enough of a nutrient to make a “source of” claim).

Types of claims:

  • Nutrition claims — “low fat,” “high fibre,” “source of vitamin C” (defined amounts required)
  • Function claims — “calcium contributes to normal muscle function” (must use authorised wording)
  • Risk reduction claims — very limited, requires specific authorisation

What you can’t say:

  • This food will cure/treat/prevent disease
  • Unauthorised health claims, even if seemingly reasonable
  • Claims that imply eating a varied diet isn’t enough
  • Claims referring to specific doctors or health professionals

Cosmetics and wellness products

Cosmetics and wellness products can make cosmetic claims but not medicinal ones. The line can be subtle:

Cosmetic claims (permitted)

  • “Reduces the appearance of wrinkles” (visual effect)
  • “Leaves skin feeling hydrated” (sensory experience)
  • “Helps improve skin’s appearance” (appearance-focused)

Medicinal claims (not permitted without a licence)

  • “Treats acne” (treats a condition)
  • “Regenerates skin cells” (physiological change)
  • “Heals damaged skin” (therapeutic effect)

Supplements

Dietary supplements can make authorised health claims (from the EU Register) but cannot claim to treat or prevent disease. “Supports immune function” may be permitted; “prevents colds” is not.

The “treats vs improves appearance” test

If your claim could be interpreted as treating a medical condition rather than improving appearance, it’s probably a medicinal claim and requires a medicine licence.

Evidence and substantiation

Healthcare claims require robust evidence:

For medicines

Claims must be based on the Summary of Product Characteristics (SmPC) — the official document describing the medicine’s properties.

For health claims on food

The scientific substantiation has already been done — you just use authorised claims. Making new claims requires going through the authorisation process.

For cosmetics

Claims should be supported by appropriate evidence. “Clinically proven” requires actual clinical trials. Consumer perception studies can support subjective claims but not objective ones.

What to ask clients:

  • What evidence supports this claim?
  • Has been through legal or regulatory review?
  • Is this a licensed indication? (for medicines)
  • Is this an authorised health claim? (for food)
  • What studies or tests back this up? (for cosmetics)

Vulnerable audiences

Healthcare advertising must be particularly careful when audiences might be vulnerable:

  • Don’t exploit anxiety — avoid creating fear to sell products
  • Don’t offer false hope — be realistic about what products can achieve
  • Don’t discourage medical advice — encourage people to consult healthcare professionals for serious conditions
  • Be careful with children — additional restrictions apply to medicines advertising directed at children

This is both an ethical and regulatory requirement. The ASA has upheld complaints against ads that exploited health anxieties.

Summary

Healthcare copywriting requires an understanding of where the line is between permitted and prohibited claims. When in doubt, err on the side of caution. Making unauthorised medical claims is a serious regulatory breach.

Work with clients who understand the regulatory framework and have compliance processes in place. If a client asks you to make claims you’re uncomfortable with, trust your instincts and push back.