Licence to open a pharmacy

License to open a pharmacy

Opening a pharmacy requires compliance with a number of legal procedures and obtaining a license. In this article, we will look at the steps required to obtain a license, the conditions under which the service can or cannot be provided, and we will also figure out how to independently prepare for this process. We will also answer common questions and discuss what determines the cost of a lawyer’s services. How much does a license to open a pharmacy in Ukraine cost?

Legal stages of opening a pharmacy

• Registration of a legal entity or individual entrepreneur: The first step is registration of a company or individual entrepreneur with the tax authorities. For a pharmacy, the most often chosen form is an LLC or individual entrepreneur.
• Obtaining the necessary documents: It is necessary to collect a list of necessary documents for opening a pharmacy, including the company's statutory documents, registration certificate, documents for premises and equipment, as well as documents confirming the qualifications of personnel.
• Preparing the premises: The pharmacy premises must comply with sanitary standards and fire safety requirements. An opinion from Rospotrebnadzor and other supervisory authorities is required.
• Conclusion of contracts: Conclude contracts for the supply of medicines with licensed suppliers, as well as contracts for the maintenance of equipment and disposal of medical waste.
• Submitting an application for a license: An application for a pharmacy license is submitted to the territorial authority. All necessary documents are attached to the application.
• Inspection and receipt of a license: After submitting the application and checking the documents, an inspection of the premises is carried out. If all checks are successfully passed, a license to carry out pharmaceutical activities is issued.

Under what conditions can legal support when opening a pharmacy be provided

• Compliance with sanitary standards: The premises must comply with all sanitary requirements and standards.
• Qualified personnel: All employees working in a pharmacy must have appropriate education and qualifications.
• Availability of necessary equipment: The pharmacy must be equipped with all the necessary equipment for storing and selling medicines.
• Conclusion of agreements: Agreements must be concluded with suppliers of medicines, service organizations and disposers of medical waste.

Under what conditions the license service for opening a pharmacy cannot be provided

• Non-compliance with sanitary standards: If the premises do not meet sanitary requirements, the license will not be issued.
• Insufficient qualifications of personnel: The lack of qualified specialists on the pharmacy staff is the reason for refusal to issue a license.
• Lack of required equipment: A license will not be issued if the pharmacy is not properly equipped.
• Violation of the law: The presence of violations of the law related to the previous activities of the company or its founders may become grounds for refusal and fines will be imposed for violations of pharmacy licensing.

How to figure it out yourself

• Studying the Legislation: Carefully study the laws and regulations governing pharmaceutical activities and licensing.
• Consulting Experts: Consult legal or pharmaceutical experts for advice and recommendations.
• Preparation of documents: Collect the entire list of documents for a license to open a pharmacy, prepare them in accordance with the requirements.
• Applying for a Pharmacy License: Follow the instructions for applying for a license.

Common questions

• How often are pharmacy licenses checked? Scheduled inspections are carried out in accordance with the annual plan approved by regulatory authorities. Usually they are carried out no more than once every three years for one legal entity.
• Cost of a license to open a pharmacy? The total costs of opening a pharmacy and obtaining a license may vary, but the basic components include: State gone. Expenses for preparation of documents and equipment. Legal services. Costs may vary depending on various factors such as region, specific requirements of local authorities and the chosen scale of business. For an accurate calculation, it is recommended to consult with professional lawyers and pharmaceutical specialists.
• Do you need insurance to obtain a pharmacy license? To obtain a license to open a pharmacy in Ukraine, insurance is not a mandatory requirement. However, there are certain types of insurance that may be recommended to minimize risks and provide business protection.
• What documents need to be submitted to renew a pharmacy license? To renew a pharmacy license in Ukraine, you must submit the following documents: Application for license renewal Copy of current license A copy of the enterprise charter or an extract from the Unified State Register of Legal Entities and Individual Entrepreneurs Documents confirming personnel qualifications (diplomas, certificates) Documents confirming the compliance of the premises with sanitary and fire standards Documents confirming ownership or lease of premises Documents confirming the availability of the necessary equipment for storing and selling medicines Agreements with drug suppliers Receipt for payment of state duty

What determines the cost of legal support when opening a pharmacy

Obtaining a license to open a pharmacy is a complex and multi-step process that requires careful preparation and compliance with all legal regulations. Contacting experienced lawyers and specialists in this field will help speed up the process and avoid possible mistakes.

• Complexity of the case: The more complex and intricate the case, the higher the cost of services will be. 
• Lawyer experience: The services of experienced and highly qualified lawyers are more expensive. 
• Region: Cost of services may vary depending on the region. In large cities it is usually higher.
•  Scope of work: The volume of legal services required and the number of specialists involved also affect the final cost.