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Effective 7 October 2020, the Saudi Food and Drug Authority (“SFDA”) issued a new Guidelines for Variation Requirements, Version 6.1 (“Guidelines”). The Guidelines classify variations and provide the basic data required for each type of variation. Namely, the new guidelines change certain variations to a new “Type” and several variations were added with various “Types” associated thereto. The Guidelines apply to changes made to drug products that have already received a marketing authorisation from the SFDA.
The Guidelines were adopted from the European Medicines Agency (EMA) Guidelines on the details of the various categories of variations, Regulation (EC) No. 1234/2008. Below, we discuss the different types of variations and the associated requirements to assist applicants in the preparation and submission of drug applications for variations to a marketing authorisation.
Below, we examine the main categories of variations, or post-marketing changes, and provide several examples and the requirements for implementing such variations.
The variation or post-marketing changes can be classified into two categories: 1) minor variations; and 2) major variations.
Minor variations that are of “Type IA” do not require prior approval before implementation. Within Type IA, those variations that are of “Type IAIN” should be submitted immediately, within 14 days following implementation, to the SFDA. Other Type IA variations can be complied and submitted to the SFDA in a single variation application no later than 31 January of each year. In general, editorial changes and typos are treated as Type IA changes.
Minor variations that are of “Type IB” must be submitted to the SFDA by the marketing authorisation holder (“MAH”) before implementation, but do not require formal approval; however, the MAH should wait to implement the change to ensure that the application is deemed acceptable before implementing the change.
Major variations of “Type II”, which may have a significant impact on the quality, safety, and efficacy of a medicinal product, do require prior approval before implementation.
Several examples of minor variations include:
Several example of major variations include:
Changes that make a new pharmaceutical application necessary, rather than a variation, include, but are not limited to:
Focusing in on additions and changes to the API supplier that has already been submitted, the following will be required to be submitted to the SFDA:
Slightly different requirements must be met in the event a Certificate of Suitability (“CEP”) is available or where a CEP is not available.
The SFDA is responsible for putting in place regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed in the Kingdom of Saudi Arabia. Please join our healthcare email list to receive more healthcare and life sciences legal and regulatory updates impacting the industry across the Middle East.