Module 6

03/10/2024

Supplementary Protection Certificates (SPCs)

The problem

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• “ On average, it takes over 12 years and costs over £ 1 billion to develop new medicines ” (Source: Association of the British Pharmaceutical Industry)

The solution

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• SPCs for medicinal products

The Organisation for Professionals in Regulatory Affairs

SPCs

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Conditions for obtaining an SPC

An SPC shall be grated if:

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a. the product is protected by a basic patent in force

b. a valid authorisation to place the product on the market as a medicinal product has been granted

c. the product has not already been the subject of a certificate

d. the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product

• ‘ product ’ means the active ingredient or combination of active ingredients of a medicinal product

• Application for an SPC must be lodged within 6 months of the date on which the marketing authorisation was granted, or the basic patent was granted, whichever is the latter.

The Organisation for Professionals in Regulatory Affairs

SPCs

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