Marketing Authorisation

Full Application
All data from MA Holder (non-patented drugs)

Abridged Application
For a generic product which can claim essential similarity to the original/reference drug, the applications made are in the form of an abridged application, where the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials.

EU Generics MA

• No MA can be granted for drug in first 10 years
• Allow development during this time

EU Paediatric Use Marketing Authorisation (PUMA)
Can retain brand name of corresponding adult product

Orphan Drug Regulation
Not exceeding 5 in 10,000 people
Financial incentives (10 year exclusivity, automatic access to CP)

EU Traditional Herbal Medicine
Two licenses exist
– Full Application
– Certificate of traditional use registration

• Full quality data
• Safety data not required if on “community list”
• Efficacy data not required if evidence that the medicinal product has been in used throughout period of last 30 years

Conditional Authorisation

Enables approval of a medicines with full efficacy requirements

Must fulfil ONE of the following

• Life threatening
• Seriously debilitating
• Public health emergency
• Orphan drug

Must fulfil ALL of the following

• An unment medical need is fulfilled
• Medicines shows positive risk:benefit ratio
• Full quality & pre-clinical data available
• Summary of Product Characteristic (SmPC) must indicate “conditional”

MA in exceptional circumstances

• Where it is unlikely full requirements will ever be met
• Specific measures required to be implemented on case-by-case basis, usualyl on epidemiological evidence

Accelerated review may be granted on requests for products of major public health interest or therapeutic innovation

Procedures relevant to the marketing authorization

Member states shall take all appropriate measures to ensure that the procedure for granting an authorization to place a medicinal product on the market is completed within 210 days of the submission of a valid application

Where a Member State notes than an application is being examined in another Member State, they may decide to suspend the detailed assessment of the application in order to await the assessment report prepared the other Member State in accordance with Article 21(4)

• The Member Sate concerned shall inform the other Member State and applicant of its decision to suspend detailed examination. As soon as it has completed the examination of the application and reached a decision, the other Member State shall forward a copy of its assessment report to the Member State concerned

Within 90 days of the receipt of the assessment report, the Member State concerned shall either recognize the decision of the first Member State and the SmPC as approved by it or reject the decision