Appeal of the Registration of Medicinal Products
Legal support in appealing of the registration of medicinal products
Registration of medicinal products is an important step in their introduction to the pharmaceutical market, however, despite the prescribed algorithm for registration of medicinal products, in practice there are a sufficient number of controversial issues related to their registration. One of the main areas of litigation is challenging the registration of medicines. Participants in the pharmaceutical market, when registering medicinal products, in practice face a number of legal issues that are often quite difficult to resolve on their own.
The main areas for appealing of the registration of medicinal products are:
- Protection of the exclusive right of the copyright holder.
- Refusal to make changes to the documents contained in the registration dossier.
- Making changes to the registration certificate of the medicinal product.
- Registration of controversial drugs in the State Register of Medicinal Products.
- Challenging the resolution of the Ministry of Health regarding the registration of a medicinal product.
- Illegal actions and decisions of the authorized body, etc.
Regardless of the type of contestation of the registration of medicinal products, it is quite difficult for participants in the pharmaceutical market to solve most of the issues of challenging the registration on their own. Often, executive authorities refuse to amend the registration certificate or the documents contained in the registration dossier, which leads to a situation where the dispute is resolved in the judiciary. At the same time, a refusal to make changes is often formed on the basis of such circumstances, for example, as the absence of documents confirming the right to represent interests in order to make changes to the registration dossier of the registration certificate holder. At the same time, there are cases in practice when the appealed decision re-registered the owner of the registration certificate of the medicinal product. Also, there are cases when there is a registration of controversial medicines, which subsequently has to be challenged. In this case, the procedure for registration of medicinal products was not observed, including the verification by the executive authority of the necessary documents submitted for state registration.
Questions on challenging the registration of medicines always attract the attention of not only regulatory authorities, but also citizens, this is primarily due to the safety of medicines used in the treatment that are in pharmaceutical circulation and the possibility of being held liable.
The procedure for Appeal of the Registration of Medicinal Products
The procedure for appealing is established in Chapter 24 of the Arbitration Procedure Code of the Russian Federation, in Article 197 of which it is established that cases of challenging the rights and legitimate interests of persons in the field of entrepreneurial and other economic activities of non-normative legal acts, resolutions and actions (inaction) of state bodies, local governments , other bodies, organizations endowed by federal law with separate state or other public powers, officials, including bailiffs, are considered by the arbitration court according to the general rules of action proceedings. At the same time, in a statement declaring a non-normative legal act of the Ministry of Health of Russia invalid, decisions and actions (inaction) illegal, the following must also be indicated:
- The name of the body or person that adopted the disputed act, resolution, committed the disputed actions (inaction).
- Name, number, date of adoption of the disputed act, decision, time of action.
- The rights and legitimate interests that, in the opinion of the applicant, are violated by the contested act, decision and action (inaction).
- Laws and other normative legal acts, which, in the applicant's opinion, the contested act, decision and action (inaction) do not comply with.
- The appellant’s demand for the recognition of a non-normative legal act as invalid, decisions and actions (inaction) illegal.
When challenging the registration of a medicinal product, it must be taken into account that cases of challenging non-normative legal acts, resolutions and actions (inaction) of bodies exercising public powers, officials are considered by a single judge within a period not exceeding 3 (three) months from the date of receipt of the relevant application to the arbitration court, including the period for preparing the case for trial and making a decision on the case.
Most controversial issues in the field of registration of medicines arise in connection with non-compliance or violation of Russian legislation regarding the registration of medicines. At the same time, the assistance of a qualified lawyer when challenging the registration of a medicinal product will greatly simplify this procedure, save time, and also minimize possible risks. At the same time, it is worth noting that the participation of a qualified lawyer at the stage of registration of a medicinal product allows entrepreneurs to conduct the registration procedure in a qualified manner and exclude the possibility of refusal to register a medicinal product.
- Legal advice on appeal of the registration of medicines
- Analysis of documents related to the registration of medicines and formation of a position to appeal the registration of medicines
- Legal support of appealing of the registration procedure of medicinal products
- Preparation and submission of documents to the court to appeal the registration of medicines
- Legal representation span