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UK Herbal Medicines

UK Herbal MedicinesCurrent Marketed Products

Most UK herbal medicines fall into the Unlicensed Herbal Medicines category. These products are currently exempt from the normal requirements for a medicine to hold a product licence or market authorisation provided they meet both of the following criteria:

  • They are legally on the UK market as an unlicensed herbal remedy in accordance with Section 12(2) of the Medicines Act 1968.
  • They were legally on the UK market before 30th April 2004.

Under these conditions, a herbal medication can remain on the UK market until the 2011 deadline. To continue marketing after 2011, these products will have to be either registered under the new Traditional Herbal Medicines Registration Scheme (THMRS) or else they will have to obtain a Market Authorisation (MA).

 

We can help you:

 

• Prepare for the new requirements.

• Reduce time to registration of your herbal product.

• Avoid spending money on development work/ unnecessary trials.

• Ensure you obtain MHRA approval for your products before the April 2011 deadline.

• Keep your product on the market.

 

This transitional period does not last forever. You will not be able to continue to place your product on the UK market after 30th April 2011.
Our team of professionals are extremely knowledgeable in the field of registration of herbal products, and have an excellent relationship with the MHRA.

 

We can also help you define whether your product is a Borderline product (it may be considered to be a food supplement) – contact CambReg for advice.
 
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