Drug registration is a key component in ensuring the safety and efficacy of pharmaceuticals. This process establishes standards and requirements for medicinal products offered to patients and healthcare institutions. Thorough review and approval ensures that products coming to market meet the highest standards of quality and safety.
Overcoming administrative and regulatory barriers in the drug registration process can be challenging. Dextralaw, whose specialists have extensive experience in this field, is ready to assist your company in all aspects of this important process and bring products to market with appropriate quality and safety assurances.
Basic rules for drug registration in Ukraine
Drug registration in Ukraine is a complex process that is subject to numerous rules and requirements. The basic rules for drug registration in Ukraine include the following aspects:
- Application submission. The applicant wishing to register a medicinal product must submit an appropriate application to the Ministry of Health of Ukraine.
- Documentation. A complete set of documents must be provided, including data on the quality, safety and efficacy of the drug.
- Clinical trials. Clinical trials may be required prior to registration of the medicinal product to confirm its safety and efficacy.
- Testing and evaluation. The drug undergoes quality, safety and efficacy testing and evaluation in accordance with requirements.
- Packaging and labeling requirements. The medicinal product must be properly packaged and labeled in accordance with legal requirements.
- Payment. The appropriate registration fee will need to be paid.
- Registration and licensing. After successful review and evaluation, the medicinal product is registered and its manufacturer is issued an appropriate license.
In parallel with the registration process, an important aspect is the possibility of re-registration of medicinal products. Since medicinal products may undergo changes such as composition, dosage, packaging, etc., their re-registration rules are also defined in relevant regulations. This process involves submitting appropriate documentation and undergoing appropriate testing and evaluation to ensure the quality, safety and efficacy of the drug after changes. Re-registration may also occur on a regular schedule or in the event of significant changes to the drug.
What documents are needed
To successfully register a medicinal product in Ukraine, a large number of different documents confirming the quality, safety and efficacy of the drug are required:
- Formal application for drug registration.
- Manufacturer’s registration certificate: information about the manufacturer of the medicinal product and its location.
- Quality certificates.
- Results of clinical trials confirming the efficacy and safety of the drug.
- Instructions for use and labeling: information for physicians and patients on the use of the medicinal product and packaging labeling.
- Copies of all necessary permits and licenses providing for the production and sale of the medicinal product.
- Results of laboratory tests and studies confirming the quality and safety of the product.
- Application for registration rights.
What our services include
Dextralaw services in the field of drug registration include:
- Consultation and support at every stage of the registration process. We will answer all your questions and provide necessary information.
- Preparation of documents. We will help collect all the necessary documentation and prepare it in accordance with the requirements of regulatory authorities.
- Clinical trials. If necessary, we can organize and provide support in conducting clinical trials to confirm the efficacy and safety of your medicinal product.
- Support during audits and inspections. We will support you during official audits and inspections by regulatory authorities.
- Recovery and re-registration. We will provide legal support if it is necessary to recover or re-register medicinal products.
Frequently Asked Questions
Registration timeframes can vary significantly depending on the complexity of the drug, the availability of clinical trials, and the workload of regulatory authorities. Typically, it can take from several months to several years.
Medicines must be properly labeled according to legal requirements. The labeling should contain information about the composition, dosage, manufacturer, expiration date, storage method and other necessary information.
Re-registration is important to ensure that medicinal products meet current standards and requirements. It allows making changes to the product’s characteristics and keeping it up to date in the market.