As soon as the MA has been granted for the medicinal product, the Marketing Authorisation Holder (MAH) is responsible for the product’s quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and European legislation. It is important to remember that depending on the country in which the medicinal product has obtained the MA, the MAH has different obligations, which must be kept in mind in order to fulfill them in a timely and diligent way.
However, the topic of this article is the MAH’s duties after obtaining the MA in Poland, and therefore we will mainly refer to the national requirements and Polish Pharmaceutical Law, and especially to the latest update regarding the aggravation of consequences resulting from failure to fulfill some of the MAH’s responsibilities in the form of financial penalties. So I kindly invite you to read this article.
One of the first obligations after receiving the MArketing Authorization
Meeting the 30-day deadline for providing samples to the National Medicines Institute (Narodowy Instytut Leków, NIL), during which 20 working days are assigned to the Institute to review the documentation and prepare a response, is quite a challenge. Therefore, NIL recently, i.e. after 02.09.2022, when the amendment of the Pharmaceutical Law came into force, proposed that in order to meet the deadline by the MAH to send product samples to the laboratory with all the necessary materials for studies, the analytical documentation should be sent to the NIL at least 6 months before the planned marketing of the medicinal product in Poland, in order to assess the completeness of the data and specify the materials necessary for the tests.
The deadline indicated by the NIL, i.e. 6 months, is often an impossible period to meet, however, this is only the NIL’s recommendation in order to assist MAH to fulfill the statutory obligation.
At the same time, we would like to emphasize that it is not obligatory to ask the NIL to specify the necessary test materials – the MAH may also make such an assessment on its own without prior consultation with the NIL.
The NIL shall provide to the Chief Pharmaceutical Inspectorate (Główny Inspektorat Farmaceutyczny, GIF) the result of a quality examination of the medicinal product, no later than 90 days from the date of receipt of the samples, together with the documentation and materials necessary for conducting a quality test of this product. The cost of the quality test, including the cost of the samples / materials and equipment needed for the analysis, shall be covered by the MAH. If the test result is inconsistent with the submitted specification, the GIF decides on further steps, and one possible option is to withdraw the medicinal product from the PL market.
Suspension and withdrawal of the medicinal product from the PL market
All rules regarding the withdrawal of medicinal products from the market are set out in the Regulation of the Minister of Health of 12th March 2008 on determining detailed rules and procedures for the suspension and withdrawal of medicinal products and medical devices from the market (hereinafter: Regulation of the Minister of Health of 12th March 2008), as amended.
According to para. 5 (1) of the Regulation of the Minister of Health, upon receipt of the GIF decision to suspend / withdraw the medicinal product from the PL market, the MAH, manufacturer or importer is obliged to prepare documents, i.e. a protocol, a report on protective measures taken and a final report, in accordance with the annexes attached to the above-mentioned regulation. The listed documents must be submitted to the GIF, if necessary, and archived for a period of 3 years , starting from the first day of the calendar year following the year in which they were prepared.
At the same time, in accordance with Article 36g (1)(15) of the Pharmaceutical Law, the MAH that has obtained the MA is responsible for notifying the President of the Office of the temporary or permanent suspension of the marketing of the medicinal product:
- at least 2 months before the date of cessation of marketing of the medicinal product;
- or immediately, if the suspension of marketing of the medicinal product is due to exceptional conditions – it should be stated whether such action is due to any of the reasons specified in Article 33 concerning the grounds for withdrawal of the MA by the President of the Office.
It should be borne in mind that according to Article 133a (1) (1) of the Pharmaceutical Law, the MAH that has not fulfilled the obligation to provide information on the temporary or permanent suspension of marketing of the medicinal product, within the specified period or has done so contrary to the facts, is subject to a fine of 500 000 PLN, which is imposed by the President of the Office by way of a decision.
At this point, it is worth mentioning that in addition to reporting product suspension, each MAH must monitor its MA for the occurrence of a sunset clause. Pursuant to Article 24 (4), (5) and (6) of Directive 2001/83/EC, as well as Article 33a of the Pharmaceutical Law, the sunset clause is a legal provision stating that the MA of the medicine will cease to be valid if the medicine is not placed on the market within three years of the MA being granted or if the medicine is removed from the market for three consecutive years.
In order to waive the effects of the sunset clause procedure, it is necessary for an application (cover letter with justification) to be submitted by the MAH, which will include a detailed justification relating to the importance of the medicinal product in terms of public health protection and indicate the existence of exceptional conditions that are the reason for not placing the product on the PL market. The application should be submitted to URPL at least 30 days before the expected expiration of the authorisation under Article 33a(1)(1) or (2) of the Pharmaceutical Law.
Proceedings to issue a decision by the President of the Office stating that MA does not expire should be completed within a maximum 30 days from the submission of a complete application.
Reneval of authorisation annual fees in Poland
Last but not least, obligation of the MAH that has obtained the MA for an indefinite period is to pay a fee during the validity period of this authorisation, for each year of its validity, in the amount of 1/5 of the application fee for the renewal of this authorisation in accordance with the Regulation of the Minister of Health dated 16.06.2015 on the fees payable in relation to placing medicinal product on the market.
As opposed to some other EU countries, in Poland the MAH must make sure to fulfill this obligation on time, as the Polish Agency does not issue invoices and delays in the payment of annual fees, which results in interest being charged by the URPL.
According to the table of fees available on the URPL’s website:
- for a product registered under the national procedure in Poland, the annual fee is PLN 2 100;
- for a product registered under the European procedure (MRP/DCP) with Poland as CMS, the annual fee is PLN 2 100;
- for a product registered under the European procedure (MRP/DCP) with Poland as RMS, the annual fee is PLN 2 730.
In summary, the MAH that has obtained the MA for the medicinal product in Poland needs to remember that under Polish legislation they are obliged to fulfill responsibilities such as:
- Notification to the GIF (30 days) and the URPL (preferably immediately) of the date of the first introduction of the medicinal product on the Polish market in the manner described in point 1 of this article;
- Submission of samples of the medicinal product along with the necessary materials/equipment to the NIL within 30 days from the date of delivery of the GIF’s decision under Article 119a;
- Notification to the President of the Office 2 months prior to the temporary/permanent suspension of marketing of a medicinal product, or immediately if the suspension is due to exceptional situations;
- Preparation of the relevant documents, as described in the Regulation of the Minister of Health of 12th March 2008 on the suspension of marketing of the medicinal product or its withdrawal, and, if necessary, submitting them to the GIF within the appropriate deadline specified in the regulation, and then archiving them for a period of 3 years, counting from the first day of the calendar year following the year in which they were prepared;
- Marketing of the medicinal product within 3 years from the date of granting the MA, and in the event of suspension of marketing, resumption of marketing within a maximum of 3 years. Otherwise, the MA may expire. In order to waive the consequences and avoid the expiration of the MA, an application should be submitted to the URPL 30 days before the expiration of the period of 3 years from the date of obtaining the MA for the medicinal product;
- Payment of annual fees in a timely manner from the date of obtaining the MA for an indefinite period.
We also invite you to read the article already available on our website regarding the post-authorisation service we provide and the sunset clause procedure.
- Have you fulfilled all of the MAH’s obligations in connection with your MA in Poland?
- Do you need support with dealing with MAH responsibilities?
- Need a helping hand wiht sunset clause?