Secondary packaging has become mandatory for medicinal products.
At the end of May 2023, a letter from the Ministry of Health and the expert center of the Federal State Budgetary Institution ‘SCEEMP’ was published on the State Register of Medicines (GRLS) with clarifications for applicants on the availability of medicines sold without secondary packaging in circulation.
- What is secondary packaging?
According to the information from the general pharmacopoeial monograph, “the elements of the primary (inner) packaging are in direct physical contact with the medicinal product and provide its protection from the influence of environmental influences during the circulation of the medicinal product. In some cases, the primary packaging is a specialized drug delivery system, such as an aerosol or dispenser, adjusted to dispense a single dose of drug.
The elements of the secondary (outer) packaging do not come into direct contact with the medicinal product, but provide the necessary protection in order to maintain stability. The secondary packaging contains one or more primary packaging units, in established cases it may contain dosing devices and means for delivering the medicinal product to the destination (measuring spoons, cups, nozzles, etc.) and additional packaging elements (knife for opening ampoules, etc.).
The secondary packaging containing the necessary information for the intended use is usually the consumer packaging.
- What should be done after publication of this letter?
The letter from the Ministry of Health of the Russian Federation and the expert center clearly states that all drugs must circulate with the secondary packaging, because otherwise provided neither by Federal Law No. 61, nor by Decision No. 78. In this regard, applicants must initiate amendments to the registration dossier in order to include information on secondary packaging.
This change will not require an examination, and can also be made to the registration dossier simultaneously with bringing the dossier in line with the rules of the EAEU.