Manufacturing for development allowed during suspensions

MFDS allows manufacture of drugs for development purposes during the drug manufacture business suspension period

Manufacturing drugs for sale is not allowed…provides interpretation in response to queries posted on the public petition website ‘e-People’

An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period.

 

According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for product development or to prepare data for approval changes, are allowed during the manufacturing suspension period.

 

This interpretation was provided after a number of queries on 'whether manufacturing for the purpose of product development is allowed during the suspension of manufacturing business period, and whether such manufactured units can be sold,’ were submitted on the national e-petition website, e-People.

 

According to Article 76 of the Pharmaceutical Affairs Act, if a manufacturer of drugs or its importer violates the Pharmaceutical Affairs Act or any order issued under the Pharmaceutical Affairs Act, the Minister of Food and Drug Safety may revoke permission, approval, or registration held by the manufacturer of drugs, issue an order to prohibit manufacturing or importing products, or issue an order to fully or partially suspend his or her business for a period of up to one year.

 

Also, according to Article 95, Annex 8-10 of the ‘Regulation on Safety of Medicinal Products,’ if companies perform the suspended business during the suspended period, their license or registration may be revoked.

 

Regarding the provisions, the industry posted an inquiry on the e-People website on whether companies subject to manufacturing suspension dispositions may conduct manufacturing activities for the purpose of preparing submission data for the product’s approval change (change of consignee) or product development (and if allowed, whether the manufactured lot may be sold).

 

After review, the MFDS said, “acts of manufacturing for non-sale, product development purposes (to prepare data for approval changes, etc.) are allowed during the manufacturing suspension period.

 

However, the sale of the lot manufactured for approval changes, etc.

 

or product development during the manufacturing suspension period is not allowed."