Do you meet SPC requirements?
You must have a valid United Kingdom (UK) patent that protects the active ingredient and a marketing authorization to place the active ingredient on the UK market as a pharmaceutical or plant protection product must have been granted.
The SPC is granted to the holder of the patent protecting the active ingredient, not to a licensee or a manufacturer of a pharmaceutical or plant protection product.
What patent can you use?
The patent can protect:
- the active ingredient,
- a process to obtain the active ingredient
- an application of the active ingredient
If you have several patents, protecting the same active ingredient you can use any of them.
What marketing authorization can you use?
The marketing authorization is either
- a national product licence issued by the Medicines and Healthcare Products Regulatory Authority, the Veterinary medicines Directorate or a valid UK plant protection product authorization,
- an authorization issued through the European Agency for the Evaluation of Medicinal Products.
It must be the first one granted to place the active ingredient on the UK market.
You should tell us if an earlier authorization for the active ingredient exists in another country of the European Economic Area. The date of the first valid authorization in the European Community, determines the length of the certificate.