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2 days ago · SPCs rely on a patent protecting the active ingredient of the medicine, and a marketing authorisation for the medicine itself. There are several different types of authorisations which currently ...
- Find Product Information About Medicines
The service provides the following types of documents: SPCs....
- Find Product Information About Medicines
- SPCS
- Pils
- Pars
Summaries of Product Characteristics (SPCs) is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.
Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. They are based on information in the SPC of the medicine
A Public Assessment Report (PAR) is a scientific assessment report available for marketing authorisations granted after 30 October 2005. This service replaces the previously separate MHRA websites, one of which hosted SPC and PILs, the other PARs.
May 16, 2014 · A Supplementary Protection Certificate (SPC) compensates for the delay. An SPC will not extend the term of your patent, but gives similar protection.
- Name of the Medicinal Product. Here the brand or trade name followed by strength and pharmaceutical form of the product can be found.
- Qualitative and Quantitative Composition. Active ingredient and the quantity they are found in the product along with other ingredients and compositions are described here.
- Pharmaceutical Form. The physical form of the medication such as ointments, capsules or injections is stated. A description of the visual appearance of the product (colour, markings, etc) and dimensions for solid oral formulation, e.g. ‘
- Clinical Particulars. Section 4.1 Therapeutic indications. The range of therapeutic indications (including the age range the medicine is indicated for) is included in this section.
Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities.
Supplementary Protection Certificates (SPCs) are linked to a granted patent, and are available across Europe. Once granted, SPCs provide additional protection for a marketable pharmaceutical or agricultural product once the related patent has expired.
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Supplementary protection certificates (SPCs) are certificates providing a supplementary market protection for pharmaceutical products in the European Union. Patents in the EU last 20 years from the filing date.