Grace period in the registration of drugs.

Regulatory affairs specialists often come across the concept of grace period. For an ordinary consumer who buys a particular drug, this phrase usually does not have any meaning. However, not only but grace period determines the “speed” of updating instructions and packaging materials on the market.

Let’s imagine the situation when the manufacturer has discovered a new contraindication to the use of drugs. This contraindication must be included in the instructions for medical use (IFU) / summary of product characteristics (SmPC) and package leaflet (PL). The regulatory affairs specialist prepares a dossier to update the above-mentioned documents and submits it to the health authorities (HA).

In case of positive decision on making changes by the authorized body, the manufacturer has some more time during which he can produce and import the drug with the “old” instruction. This period of time is called grace period.

Interestingly, in different countries, regulators have different attitudes towards the grace period. In a number of countries, it does not exist (as, for example, in Mongolia. There is even no mention of a grace period in the legislation), in other countries the granting of a grace period depends on changes. For example, in Armenia there is no grace period for safety-related changes, but for changes in packaging materials it can be 6 months. In Azerbaijan, grace period is provided only in case of changes type IA.

In the Russian Federation, in accordance with Article 30 of Federal Law No. 61 “On the Circulation of Medicines: “It is allowed to circulate medicinal products for medical use before the expiration date, produced within one hundred and eighty days after the date of the decision by the authorized federal executive body to amend the documents contained in the registration dossier, in accordance with the information contained in the documents of the registration dossier for the medicinal product before the date of such decision”.

Registration of drugs in Russia, EAEU & CIS countries –