Shelf Life of Medicinal Products: Russian Legal Regulation

Anna Ivanova, Associate at BRACE Law Firm ©

January 12, 2022

Under Article 472 of the Civil Code of the Russian Federation (the "Civil Code"), shelf life is the period after which a product becomes unfit for its intended use. Simultaneously, the law imposes an obligation on the seller to transfer the product to the buyer in a manner that allows the buyer to use it before the shelf life expires. In practice, manufacturers establish shelf lives for many products. However, establishing shelf lives for medicinal products plays a particularly critical role.

As a general rule under Article 46 of Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products"), medicinal products may enter circulation only if the required information, including the shelf life, is clearly printed in Russian on the primary packaging. Similar requirements apply to the secondary packaging of a medicinal product.

Specifically, in pandemic conditions, authorities recommend paying close attention to verifying documents for consistency regarding batch numbers, medicinal product names, and acceptable shelf lives. A product in vials or ampoules is unfit for use if the integrity of the packaging or labeling is compromised, physical properties have changed (such as turbidity or discoloration), the shelf life has expired, or storage conditions were improper.[1]

Establishing the Shelf Life of Medicinal Products

The Board of the Eurasian Economic Commission (the "EEC") has developed a guideline for calculating the shelf life of medicines. Generally, the batch release date of a medicinal product should not exceed 30 calendar days from its manufacturing date. The shelf life expiration date of a medicinal product batch is calculated from its release date.

The manufacturing date of a medicinal product is the date of the first operation involving the mixing of the active pharmaceutical ingredient (API) with other ingredients. For medicinal products with a shelf life of less than 12 months, the manufacturer specifies the manufacturing date in the format DD.MM.YYYY or DD/MM/YYYY (day, month, calendar year). In all other cases, the format is MM.YYYY or MM/YYYY (month, calendar year).

For medicinal products consisting of a single API in primary packaging without other ingredients, the manufacturing date is the initial date of packaging (filling the primary container).

For medicinal products (such as radiopharmaceutical medicinal products) with a shelf life of less than 12 months, the expiration date is established by adding the shelf life to the batch release date.

For medicinal products with a shelf life exceeding 12 months, the expiration date is established as follows:

• By adding the shelf life to the batch release date—if the manufacturer produced the medicinal product after the 15th day of the month.
• By adding the shelf life to the batch release date and specifying the month preceding the month obtained by adding the shelf life—if the manufacturer produced the medicinal product before the 15th day of the month.

The shelf life expiration date is calculated from the batch release date. However, if the period between the manufacturing date and the release date exceeds 30 calendar days, it is calculated from the manufacturing date.[2]

Regarding biological medicinal products, according to EAEU standards, the expiration date is established based on the actual data contained in the registration dossier. Since the shelf life of a product is established based on real-time stability studies conducted at actual temperatures, the applicant must update the initial stability data during the expert examination process.

If the applicant submitted results from testing pilot batches to establish the shelf life, but the product manufactured on a commercial scale fails to meet the long-term stability specifications derived from pilot batch storage or does not reflect the properties of the material studied in preclinical and clinical studies, the applicant must notify the authorized bodies to determine further tactics.[3]

Shelf life also holds immense significance when studying the stability of medicinal products. The objectives of stability studies are to obtain data on how the quality of a medicinal product changes over time under the influence of various environmental factors (temperature, humidity, and light), as well as to establish recommended storage conditions, retest periods for stable APIs, and shelf lives for low-stability medicinal products.

Generally, shelf life acceptance criteria should be established taking into account available stability information. Based on stability assessments and changes occurring during storage, justified discrepancies between the shelf life acceptance criteria and the release criteria are permissible. For medicinal products with a proposed shelf life of at least 12 months, the frequency of long-term stability studies should generally be every 3 months during the first year, every 6 months during the second year, and annually thereafter throughout the proposed shelf life.[4]

Additionally, starting December 10, 2022, special rules for stability studies of herbal medicinal products will take effect. Under these rules, for herbal medicinal products where the constituents with known therapeutic activity have not been established, the minimum content of an analytical marker established for the herbal API by the Pharmacopoeia of the Eurasian Economic Union (the "Union Pharmacopoeia")—or, in its absence, by the pharmacopoeias of EAEU member states—cannot be used as a stability criterion at the end of the shelf life.[5]

Shelf Life of Medicinal Products in Procurement

According to Decree of the Government of the Russian Federation No. 1380 dated November 15, 2017, On the Specifics of Describing Medicinal Products for Medical Use as an Object of Procurement for State and Municipal Needs, when describing a procurement object, the Customer must specify the residual shelf life of the medicinal product expressed in units of time (for example, "no earlier than January 1, 2020" or "at least 12 months from the date of the contract").

However, as FAS Russia notes, the most typical example of restricting the number of bidders in pharmaceutical procurement is specifying therapeutically insignificant characteristics that correspond to specific trade names without the possibility of supplying an equivalent product. This includes specifying the residual shelf life as a percentage.[6]

In fact, according to the established practice of FAS Russia, specifying the residual shelf life as a percentage is considered unlawful. For example, Bidder 1 proposes a medicinal product with a registered shelf life of 3 years, and Bidder 2 proposes one with 2 years. The Customer acquires the product to cover needs for 1 year but sets the residual shelf life at 70%. Consequently, to meet the requirements, Bidder 1 must supply a product with 2.1 years of residual shelf life, while Bidder 2 must supply one with 1.4 years. The residual shelf life of both bidders' products covers the Customer's period of need. Thus, Bidder 1 is forced to supply a product with a shelf life 1.5 times longer than that of Bidder 2. Therefore, economic entities offering medicinal products with different shelf lives (or different residual shelf lives despite having the same registered shelf life) are placed on unequal footing when Customers set shelf life requirements in percentages.[7]

Nevertheless, judicial authorities sometimes take the opposite position regarding the use of percentages for residual shelf life. For instance, the Arbitration Court of the West Siberian District concluded that current legislation does not prohibit calculating the residual shelf life of goods (medicinal products) as a percentage.[8] However, it is important to note that this judicial practice has not been established at the level of the Supreme Court. Consequently, regional courts may provide different assessments of percentage-based shelf life requirements depending on the specific dispute. To avoid litigation, Customers are recommended to follow the guidance of FAS Russia. Alternatively, when appealing a regulatory body's decision in court, it would be necessary to prove that specifying the residual shelf life as a percentage did not lead to a restriction of competition under the law.

Consequences of Dispensing or Supplying Expired Medicinal Products

Under Article 5(5) of Law No. 2300-1 dated February 7, 1992, On the Protection of Consumer Rights (the "Law on Consumer Rights Protection"), the sale of goods (or performance of work) after the expiration of the established shelf life, as well as goods for which a shelf life must be established but is not, is prohibited.

Despite the direct prohibition on selling expired goods, such precedents currently exist.

If a defect is identified in a product, under Article 18 of the Law on Consumer Rights Protection, the consumer may:

• Replace it with a product of the same brand;
• Replace it with a similar product of a different brand (model, article) with a corresponding recalculation of the purchase price;
• Reject the product and demand a refund of the amount paid, while returning the defective product to the seller.

Thus, if a pharmacy sells expired medicines, the consumer has the right to demand a replacement or a refund. If the seller refuses to process the return, the consumer should submit a written claim (to provide evidence of the request) and file a complaint with the relevant department of Rospotrebnadzor.

Similarly, in the case of wholesale supply, under Article 518 of the Civil Code, a buyer (recipient) who receives goods of inadequate quality may demand that the supplier provide goods of adequate quality or reject the goods and demand a refund of the purchase price.

Furthermore, under Article 14.43 of the CAO RF, a violation of technical regulations by a manufacturer, contractor (a person performing the functions of a foreign manufacturer), or seller entails an administrative fine of 1,000 to 2,000 rubles for individuals; 10,000 to 20,000 rubles for officials; 20,000 to 30,000 rubles for individual entrepreneurs; and 100,000 to 300,000 rubles for legal entities. These sanctions also apply to dispensing goods after their shelf life has expired. For example, a pharmacy was held liable under this article because it circulated a medicinal product without secondary packaging and with compromised primary packaging that lacked batch numbers and expiration dates.[9]

In another court decision, a ruling to hold an organization liable under Article 14.43 of the CAO RF was upheld because it violated the Rules for the Storage of Medicinal Products (Order of the Ministry of Health and Social Development of the Russian Federation No. 706n dated August 23, 2010) and the Rules of Good Storage and Distribution Practice for Medicinal Products for Medical Use (Order of the Ministry of Health of Russia No. 646n dated August 31, 2016). Specifically, the organization stored expired medicinal products together with other groups of medicinal products.[10]

Additionally, it is important to note that not only trading organizations but also medical institutions are liable for storing expired medicines. For instance, a court of general jurisdiction upheld a decision to hold the director of a medical institution liable because expired medicinal products were stored together with medications intended for medical use.[11]

Therefore, all wholesale and retail pharmaceutical organizations, as well as medical organizations, must comply with storage periods based on shelf lives and strictly observe the prohibition on the sale of expired medicines.

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References

[1] Letter of the Ministry of Health of Russia dated December 22, 2021 No. 30-4/I/2-21694 On Sending Updated Temporary Methodological Recommendations On the Procedure for Vaccination Against the New Coronavirus Infection (COVID-19).

[2] Recommendation of the Board of the Eurasian Economic Commission dated February 26, 2020 No. 2 On the Guideline for Calculating the Shelf Life Start Date for Finished Pharmaceutical Forms of Medicinal Products for Human Use and Veterinary Medicinal Products.

[3] Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 89 On Approval of the Rules for Conducting Studies of Biological Medicinal Products of the Eurasian Economic Union.

[4] Decision of the Board of the Eurasian Economic Commission dated May 10, 2018 No. 69 On Approval of the Requirements for Stability Studies of Medicinal Products and Pharmaceutical Substances.

[5] Decision of the Board of the Eurasian Economic Commission dated December 7, 2021 No. 169 On Approval of the Requirements for Stability Studies of Herbal Pharmaceutical Substances (Products Based on Herbal Raw Materials) and Herbal Medicinal Products.

[6] Letter of FAS Russia dated June 9, 2015 No. AK/28644/15.

[7] Letter of FAS Russia dated August 26, 2014 No. AK/34487/14 On Clarification of Issues Regarding the Establishment of Residual Shelf Life for Medicinal Products by State and Municipal Customers in Procurement Documentation.

[8] Resolution of the Arbitration Court of the West Siberian District dated July 6, 2017 in Case No. A27-19494/2016.

[9] Ruling of the Supreme Court of the Russian Federation dated July 26, 2021 No. 308-ES21-8342.

[10] Ruling of the Supreme Court of the Russian Federation dated June 20, 2019 No. 301-AD18-25805.

[11] Decision of the Avtozavodsky District Court of Nizhny Novgorod in Case No. 12-333/19.