Herbals (Europe)

As from 1st May 2011 all manufactured herbal medicines (also known as botanical medicine, phytomedicine and phytotherapy) must be registered in Europe.  If herbal companies do not comply, they will not be allowed to sell their herbal medicines until registration has been approved.

Global Regulatory Services can help herbal companies throughout the registration process.  We understand and appreciate that, in many instances, the workload now required to comply with the new herbal regulations has not been planned or budgeted for.  Any cost which hasn't been included in a company's business plan always feels expensive.  By using our services, however, you will be tapping into our regulatory knowledge and expertise which will save you time and therefore, money.  We can take on all your regulatory tasks so that you can continue to achieve your planned objectives.  Alternatively, you may prefer us to 'hold your hand' throughout the registration process.  This will enable you to have a better understanding of the rules and regulations which are relevant to your herbal products giving you the opportunity to incorporate this new found knowledge into your future business strategy.

** New Service **

As a result of the EU Herbal Directive coming into full force on 1st May 2011, GRS has been extremely busy conducting herbal product assessments.  Our Herbal Team has been working almost 24/7 to turn these around so that companies can act now to ensure their products can remain on the market or be re-launched in the very near future.  The Team has a lot of knowledge and experience in this field.  GRS is happy to take on a single product assessment or review a client's entire herbal product portfolio.  Prompt turn around times can be assured.

A GRS product assessment consists of a high level review (including literature and comparator product research) on the product in question (particularly its ingredients) against certain regulations.  These regulations can vary according to a client's needs and can include an assessment against the regulations for:

  • food and/or food supplement with health claim
  • traditional herbal remedy
  • medical device
  • cosmetic
  • full product licence

The resulting report will outline where compliance is, and is not, met; what information is needed to reach compliance and some initial recommendation(s) on wording and reformulation of the product (if needed).

If you would like to explore this further, please do not hesitate to contact us with your specific regulatory compliance requirements.

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