Toxins, or anything containing Botulinum Type A toxin (Botox, Bocouture, Azzalure etc.), are classed as a medicine in the UK (United Kingdom). This means that their supply, and use, are regulated and they can only be purchased on Prescription and from a Pharmacy.

Pharmacies can only purchase Toxins from a Licensed Wholesaler or the Manufacturer themselves.

If you purchase a Toxin, or a Clinic/Practitioner offers you Toxins without a Prescription, then this sale is not legal and comes with risks, some of which are life changing.

 

Recent press articles have highlighted the use of unlicensed toxins in aesthetics

Did you know the use of the term ‘Unlicensed’ (commonly referred to as ‘specials’ within the Pharmaceutical Industry) when used to describe a medicine, does not necessarily mean that it is ‘not regulated.’

In fact, the use of Unlicensed medicines does play a role within healthcare and can include medicines that are licensed in other countries but not available in the UK.

For example:

A Medicine can be licensed in the UK in one form (e.g. a tablet) but then unlicensed in another form (e.g. oral liquid) to make it easier for patients to take.

Or it may be licensed for one illness but prescribed for another.

So, Can Unlicensed Toxins be Used in the UK?

Unlicensed medicines can be manufactured or imported into the UK under extremely strict conditions and with oversight from the MHRA (Medicines and Healthcare products Regulatory Agency).

One such restriction for the importing and purchasing of unlicensed medicines in the UK is that there cannot be a licensed version already available. In the case of Toxins, there are several UK licensed products available already, therefore it would be impossible to get the authority to legally trade in an ‘unlicensed’ version.

The recent press articles referencing unlicensed toxins are referring to branded products available in other countries which are not licensed in the UK. Until these Toxins are licensed, there is a huge risk for the clinic and the end user.

 

Key Points In relation to the ‘Black-Market Toxins’ recently reported in National Media Outlets

While the products referenced may be legitimately traded in other countries outside the UK, until they have been approved by MHRA they are not legally approved for sale or use. Infact:

  • Trading of these products is not legal in the UK.
  • These products have not been assessed to UK standards. While it is possible that the products have been manufactured to appropriate standards, they also may not be. There is no way to tell if quality and safety standards have been met.
  • There is no oversight of the information supplied to the patient regarding these products. In the UK, all licensed products will contain a patient information leaflet with approved text to inform the patient about the medicine. An unlicensed product may contain incorrect or out of date information, or no information at all.
  • There will be no regular post-marketing surveillance or assessment of these products. This means that reports of adverse reactions are not monitored, communicated, or acted upon and so the safety of the products, and safety of the patients who have been treated, is at risk.
  • There is no traceability of the products in the supply chain. Therefore, any serious defects that would result in a recall will not be identified or enacted upon.
  • The authenticity of the medicine cannot be confirmed.There is a chance that it could be counterfeit (https://www.teleta.co.uk/guest-blogger/top-tips-to-help-identify-fake-dermal-fillers-aesthetic-products/ ) which may mean it does not contain any toxin at all, contains the incorrect strength, has been manufactured in an unsafe facility or may contain other chemicals which are dangerous.

How Do You Determine if a Product is Licensed?

You can identify all licensed medicines in the UK using the following methods:

  • All licensed medicines will have a PL Number on the outer packaging. It will usually be in the format PL XXXXX/YYYY, and the name and address of the Marketing Authorisation holder (license holder) will be included.
  • The MHRA have copies of all printed materials for licensed products available from their website (https://products.mhra.gov.uk/)
    • If you are looking for toxins, type in ‘botulinum’ and press search.
    • It takes a little time to get used to the site but if you filter by Summary of Product Characteristics (SPC) then each product will only appear once.
    • If you would like to see the Patient Information Leaflet, then use this filter.
    • The PL number on the website will match the PL number on the packaging.
  • All licensed medicines will have the text POM (Prescription Only Medicine), P (Pharmacy) or GSL (General Sales List) inside a square box printed on the outer packaging.
  • Toxins are a POM (Prescription Only Medicine) which means that they can only be purchased for an end user on prescription.
  • Prescription medicines can only be supplied to the end user via a Registered Pharmacy. You can check their registration with the General Pharmaceutical Council (GPhC) (https://www.pharmacyregulation.org/registers/pharmacy). Some online pharmacies will provide a direct link to their registration from their own website. Look for the Registered Pharmacy logo and click on it to confirm the details.
  • Pharmacies can only purchase from the manufacturer or an authorised wholesaler who are WDA approved. These can be confirmed with the MHRA ( https://cms.mhra.gov.uk/mhra)

At Teleta we have both a Pharmacy Registration and a Wholesale Dealer’s License. This means that we are registered and regulated with two different authorities, the MHRA and GPhC (https://www.pharmacyregulation.org/). As a result, the company is regularly audited to ensure that our processes comply with strict UK standards.

Additionally, individuals named on the licenses have personal responsibility for compliance with the relevant regulations. This means accountability is assigned to the individuals as well as the company.

We all recognise the potential we have within this industry to positively impact people’s lives. Whether you are a Consumer, Practitioner, Manufacturer or Supplier, safety and confidence in your product always comes first.

If you have any questions relating to this article, please get in touch at support@teleta.co.uk or call 01355 204 448.

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