PDRN and Polynucleotides in the UK: Cosmetics Rules, Injectables and the MHRA (2026)

Quick answer

In the UK, PDRN skincare (serums, creams, toners) is regulated as a cosmetic. It must be safety-assessed, notified to the Office for Product Safety and Standards (OPSS) and sold without claims to treat or heal. Polynucleotide and PDRN injections are a separate category: an injectable product, generally marketed as a medical device, plus a procedure. The MHRA regulates medicines and medical devices, but it does not "approve" individual aesthetic treatments. Who may inject is changing: Scotland passed a law in 2026, and England's licensing scheme is still being developed.

This is general information about UK rules, not legal or medical advice. Rules change. Check the official sources linked below.

In this guide

• 1. PDRN skincare is a cosmetic
• 2. Polynucleotide and PDRN injections
• 3. Who can give polynucleotide injections? (2026)
• 4. Practical checklist
• Frequently asked questions
• References

1. PDRN skincare is a cosmetic

In Great Britain, cosmetics are regulated under Regulation (EC) No 1223/2009 as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. This is usually called the UK Cosmetics Regulation [1]. A PDRN serum sold in Boots or online has to meet the same rules as any other cosmetic.

What every PDRN cosmetic needs [1]:

• A UK Responsible Person with a UK address. This can be the manufacturer, importer or an appointed company, and a PO box does not count.
• A safety assessment by a qualified safety assessor. It is recorded in a Product Information File kept for 10 years after the last batch.
• Good manufacturing practice, normally shown through ISO 22716.
• Notification to OPSS through the Submit Cosmetic Product Notifications service before the product goes on sale [1][2].
• A full ingredient list. This is where you see "Sodium DNA", the usual name for PDRN on labels.

The claims rule. OPSS guidance says that cosmetic labelling and advertising "must not imply they have characteristics or functions which they do not have". It also says the Responsible Person must "be able to prove that any claims made when marketing the product are correct" [1].

When a PDRN cosmetic becomes a "medicine"

The MHRA decides "borderline" cases. A product counts as a medicinal product if it is presented as preventing or treating disease, or if it functions by "restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action" [3]. In this test, disease "includes any injury, ailment or adverse condition".

The MHRA looks at explicit and implied claims across "labelling, packaging, promotional literature, advertisements, websites, social media and customer reviews" [3]. In practice, wording like this can push a skincare product towards medicine territory:

• "Heals wounds", "treats acne scars", "cures eczema"
• "Repairs damaged DNA" or "regenerates tissue"
• "Works like an injection" when the claim implies a medical effect

Cosmetic wording such as "helps improve the appearance of fine lines" or "supports a hydrated-looking complexion" stays on the cosmetic side, as long as it can be substantiated.

Why this matters for PDRN: much of PDRN's research is about wound healing and tissue repair (see our clinical evidence review). Borrowing that language for a serum is exactly what the claims rules are designed to stop.

2. Polynucleotide and PDRN injections

Clinic treatments sold as "polynucleotides", "salmon DNA" or "PDRN injections" involve two separate things:

1. The injectable product. Products sold to UK clinics are generally marketed as medical devices. A device must act mainly by physical or mechanical means, not pharmacologically [4], and industry and clinic sources describe polynucleotide injectables as class III, the highest-risk class. Medical devices in Great Britain need a UKCA mark from a UK Approved Body or a recognised CE mark. On 21 October 2026, the government confirmed it will continue to accept CE-marked medical devices on a long-term basis [5][6]. Check which mark and class apply to the specific product you are offered.
2. The procedure. The practitioner, premises and aftercare. These are covered by the separate (and changing) rules in section 3.

"MHRA approved" — what it does and doesn't mean

The MHRA is the regulator for medicines and medical devices in the UK. For most medical devices, it does not issue the conformity certificate itself. That is done by an Approved Body (for UKCA) or an EU Notified Body (for CE) [6]. A clinic describing a polynucleotide as "MHRA approved" is therefore usually being imprecise. A clearer description is "a CE- or UKCA-marked medical device", which you can check.

The device route also differs from botulinum toxin, which is a prescription-only medicine. That is why toxin treatments need a prescriber and cannot be advertised to the public. Polynucleotide devices are not prescription-only medicines, but advertising for them must still be truthful and substantiated under the UK advertising codes (CAP Code), which the ASA enforces.

Injectable PDRN as a medicine elsewhere

In some countries, injectable PDRN is licensed as a medicine. Examples are Italy, where the major diabetic foot ulcer trial was run, and South Korea. Its evidence comes from that medical use. A product's legal status in one country does not carry over to the UK.

3. Who can give polynucleotide injections? (2026)

There is no single UK rule. Each nation is moving at a different speed.

Where do polynucleotides sit in England's planned tiers?

They have not been named yet. The 2023 consultation proposed green, amber and red tiers. It listed "biorevitalization injections and/or any injection of hyaluronic acid" in the amber tier, which in practice often includes skin boosters [7]. The government response says "further work is required to determine where specific procedures will sit". Until a final list is published, it is wrong to say polynucleotides are definitely amber or red.

Existing UK law already restricts some treatments. In England, the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 bans these treatments for under-18s for cosmetic purposes. We have not found a law that names polynucleotides specifically.

4. Practical checklist

Buying PDRN skincare

• Is there a UK or EU address for the Responsible Person on the pack?
• Is "Sodium DNA" or a named PDRN ingredient on the full ingredient list?
• Does it avoid medical claims (heal, treat, regenerate, repair DNA)?
• Is the source stated (salmon, trout or "plant")? See Is PDRN vegan?

Booking a polynucleotide treatment

• What is the exact product, and is it CE- or UKCA-marked? Ask to see the packaging.
• Who is injecting? Check their registration with the GMC, NMC, GDC or GPhC, and ask who prescribes if anything goes wrong.
• Is the clinic registered where that is required (for example, with the CQC in England for regulated activities, or with HIS in Scotland)?
• Is there a written consent, aftercare and complications plan?
• Be wary of "MHRA approved", "no risk" or "permanent results" claims.

For safety evidence, read Are PDRN injections safe? For a direct comparison, see PDRN skincare vs salmon DNA facials.

Frequently asked questions

Is PDRN legal in UK skincare?

Yes. PDRN (usually listed as Sodium DNA) can be used in cosmetics sold in Great Britain, provided the product meets the UK Cosmetics Regulation: a safety assessment, a Responsible Person, OPSS notification and lawful claims [1].

Are polynucleotide injections regulated by the MHRA?

The MHRA regulates medical devices and medicines in the UK, which includes the injectable products. It does not normally issue device certificates itself or license individual clinics or practitioners. Practitioner rules come from separate laws in each UK nation [6][7].

Do you need to be a nurse or doctor to give polynucleotides in the UK?

In England, there is not yet a specific legal requirement for polynucleotides, but the planned licensing scheme will restrict higher-risk procedures [7]. Scotland's 2026 law will require regulated settings [8]. Choosing a registered healthcare professional is the safer option now.

Can a PDRN cream claim to repair skin?

It can say it helps improve the appearance of skin if the claim can be substantiated. Claims to heal, treat or regenerate tissue risk making it a medicinal product in the MHRA's eyes and break cosmetic claims rules [1][3].

Are polynucleotides banned for under-18s?

Not by name in England yet, although the planned scheme intends age restrictions [7]. Scotland's new law makes it an offence to provide regulated procedures to under-18s [8].

References

1. Office for Product Safety and Standards. Making cosmetic products available to consumers in Great Britain. GOV.UK. Link

2. OPSS. Submit a cosmetic product notification. GOV.UK. Link

3. MHRA. Borderline products: how to tell if your product is a medicine (updated 2 July 2026). GOV.UK. Link

4. MHRA. Borderline products: how to tell if your product is a medical device. GOV.UK. Link

5. Department of Health and Social Care / MHRA. Government confirms indefinite recognition of CE marked medical devices (21 October 2026). GOV.UK. Link

6. MHRA. Medical devices: conformity assessment and the UKCA mark. GOV.UK. Link

7. Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation response (7 August 2025). GOV.UK. Link

8. Scottish Parliament. Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Bill. Committee news, 27 January 2026 — editor: replace with the Bill page / Act on legislation.gov.uk once Royal Assent is confirmed.

9. Welsh Government. Wales first in UK to implement licensing for special procedures (29 November 2024). Link