Requirement of 8 years to allow marketing of similar products

The Ministry of Health sets controls for the use of data on innovative drugs in the country

In exceptional cases, marketing approval for an innovative drug may be granted before the time limit expires.

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The Ministry of Health and Prevention has set controls for the use of information and data on innovative pharmaceutical products, and has set requirements that must be met before giving marketing approval for similar pharmaceutical products in the country, most notably the eight years since the registration of the innovative drug product.

According to Ministerial Resolution No. 321 of 2020 regarding the use of information and data on innovative medicinal products, issued by the Minister of Health and Community Protection Abdulrahman Al-Owais, finally, it is not permissible for the applicant to obtain marketing approval for any drug product similar to an innovative drug product, use the information and data for clinical research. And pre-clinical for an innovative medicinal product that has obtained marketing approval from the Ministry, except after eight years have passed from the date of issuance of the marketing approval for the innovative product in the country.

An innovative medicinal product is considered a medicinal product that contains an active ingredient for which no other medicinal product containing the same ingredient has previously obtained marketing approval in the country.

The Ministry affirmed that it is not permissible to grant marketing approval for similar pharmaceutical products to innovative pharmaceutical products that obtained marketing approval from the Ministry before the expiration of eight years, and it is also permissible during the last two years of this period to submit a request to obtain approval for the total manufacture of an identical drug product in the country.

She pointed out that everyone who requests obtaining marketing approval for an equivalent medicinal product must provide evidence that the relevant innovative medicinal product does not have a patent document valid in the country.

According to the ministerial decision, it is permissible in exceptional cases and for the purpose of protecting public health in the community to grant marketing approval for similar pharmaceutical products to innovative products that obtained marketing approval from the Ministry before the expiration of the mentioned period, and marketing approval may be granted for a drug product similar to an innovative drug product that obtained marketing approval from the Ministry before The expiration of the period (eight years), in the event of submission of evidence indicating the approval of the holder of the right to market the innovative medicinal product.

Marketing approval

The Ministry of Health and Community Protection stated that the provisions of the decision apply to pharmaceutical products that obtain marketing approval by it, after the date of its publication, and for medicinal products registered in the Ministry or that obtained marketing approval before that date, the provisions of Ministerial Resolution No. 404 regarding the registration of drugs and preparations remain in effect. Pharmaceutical.

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