post-bg-466
calendary July 2, 2024

Mock-ups and labeling as part of the registration dossier for a medicinal product

Section 1.3.2 of Module 1 of the registration dossier for a medicinal product requires the provision of mock-ups and labeling text, which are drawn up in accordance with Decision 76.

As a rule, in the most typical cases, when registering a drug/harmonization of the dossier with the requirements of the EAEU, the following is submitted:

  1. Mock-ups of secondary (consumer) packaging - packaging in which medicine is placed in primary or intermediate packaging for sale to the consumer;
  2. Mock-ups of primary packaging - packaging in direct contact with the drug;
  3. The text of the labeling which is a separate document that contains information printed on the packaging (primary and secondary in the typical case) of the medicinal product.

In some cases, mock-ups of intermediate packaging are also provided.

According to Decision 76, the following information is indicated on the primary packaging:

  1. Trade name of the drug;
  2. International nonproprietary name (INN) (if available) or common (group) name - may not be indicated if the primary packaging is small;

Dosage form – may not be indicated if there is secondary packaging;

  1. Dosage and (or) activity and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
  2. The number of medicines in the package – may not be indicated if there is secondary packaging;
  3. Route of administration – may not be indicated if included in the name of the dosage form;
  4. The name or logo of the marketing authorization holder (MAH) or manufacturer (if necessary) of the drug - may not be indicated if the primary packaging is small;
  5. Serial number;
  6. Expiration date ("best before...").

Secondary packaging must contain the following information:

  1. Trade name of the drug;
  2. INN (if available) or common (group) name;
  3. Names of MAH and drug manufacturer;
  4. Address of MAH and drug manufacturer;
  5. Dosage form;
  6. Dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
  7. Number of medicines in the package;
  8. Information on the composition of the drug;
  9. Serial number;
  10. Manufacturing date;
  11. Expiration date (“best before...”);
  12. Storage conditions and, if necessary, transportation conditions;
  13. Route of administration - may not be indicated if included in the name of the dosage form;
  14. Dispensing requirements;
  15. Warning notices;

MAH has the right to indicate the full composition of the drug, but is not obliged to do so. However, there is a list of excipients, the indication of which is mandatory (Annex 1 to Decision 76) on the secondary packaging of medicinal products for oral administration. These include, for example, lactose and various azo dyes.

References:
  1. Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 N 76 (as amended on September 23, 2022) “On approval of the Labeling Requirements for Medicines for Medical Use and Veterinary Medicines”

More related posts

new-img-1

Control

Fine for spa resort in Yessentuki

Roszdravnadzor has imposed a fine of 130 thousand rubles on a spa resort in Yessentuki for improper storage of medical products…

03.03.2016
READ ARTICLE
new-img-2

Roszdravnadzor

Roszdravnadzor – patients’ rights

In 2015, Roszdravnadzor restored the rights of more than 460 thousand citizens to effective, accessible, and safe medical…

03.03.2016
READ ARTICLE
new-img-3

Regulation

The certification scheme for medical products hasn’t changed recently

Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the…

03.04.2016
READ ARTICLE
new-img-4

Control

Fines – Rostov region

In one and a half months of 2016, the Local Agency of Roszdravnadzor in Rostov Region imposed fines of the total amount of…

03.10.2016
READ ARTICLE
new-img-5

Control

Unregistered medical products

Two citizens were fined for selling unregistered medicinal products on the Internet in the Republic of Bashkortostan.

03.10.2016
READ ARTICLE
new-img-6

Control

Unscheduled inspection by roszdravnadzor

Roszdravnadzor started an unscheduled inspection of the Federal State-Funded Institution of Sverdlovsk Region Kirovgrad Central…

03.14.2016
READ ARTICLE
new-img-7

Medical Devices

International medical device regulators forum (IMDRF)

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor,…

03.17.2016
READ ARTICLE
new-img-8

Pharmaceuticals

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF”

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF” in which pills the metal wire was found.

05.18.2016
READ ARTICLE
new-img-9

Roszdravnadzor

Medical equipment stands idle in the Pskov region

Roszdravnadzor (RZN) statement: the expensive medical equipment for the total amount of 342 million rubles stands idle in…

05.19.2016
READ ARTICLE
new-img-10

Control

Hospital control Jewish autonomous region

Roszdravnadzor has audited the activity of the Regional Budgetary Public Health Facility “Central district hospital of Lenin”…

05.20.2016
READ ARTICLE