Poland offers a plethora of opportunities for foreign entrepreneurs and investors looking to establish their pharmaceutical business in the country. The favourable regulatory environment, skilled workforce, and lower costs of labour and utilities make it an ideal destination for investors. However, registering a pharmaceutical business in Poland can be a complex process, requiring diligence and patience. In this article, we will provide you with a step-by-step guide on how to register your pharmaceutical business in Poland, benefits, documents required, costs and how OnDemand International assists you.
Landscape of pharmaceutical business in Poland
The Polish pharmaceutical industry is governed by the Pharmaceutical Law, which outlines the stringent regulations and procedures for registering and operating pharmaceutical businesses. The Chief Pharmaceutical Inspectorate (GIF) serves as the regulatory authority, overseeing the approval and authorization of medicinal products, ensuring compliance with quality standards, and safeguarding public health.
Types of Pharmaceutical Businesses in Poland
The Polish pharmaceutical landscape encompasses a diverse range of business structures, each with its own set of requirements and considerations. Here’s an overview of the main types:
- Pharmaceutical Manufacturers: Companies engaged in the production of medicinal products must possess the necessary manufacturing licenses and demonstrate compliance with Good Manufacturing Practices (GMP).
- Wholesale Distributors: Entities responsible for distributing medicinal products to pharmacies must obtain wholesale distribution authorization from the GIF and adhere to strict storage and handling regulations.
- Pharmacies: Retail pharmacies dispensing medicinal products to the public must be managed by a licensed pharmacist and comply with stringent pharmacy regulations.
Steps to Register a Pharmaceutical Business in Poland
The process of setting up a pharmaceutical business in Poland is:
- Create a Business Plan: The initial step to start a pharmaceutical business is to ceate a comprehensive and detailed business plan.
- Choose a Business Structure: Determine the most suitable business structure for your pharmaceutical venture, considering factors such as liability, taxation, and management control.
- Obtain a Business Permit (NIP): Register for a business identification number (NIP) with the Central Register and Information on Economic Activity (CEIDG).
- Secure a Registered Office: Establish a physical address for your pharmaceutical business within Poland.
- Obtain Necessary Licenses and Authorizations: Depending on the type of pharmaceutical business, apply for the requisite licenses and authorizations from the GIF, such as a manufacturing license or wholesale distribution authorization.
- Comply with Regulatory Requirements: Ensure adherence to all applicable pharmaceutical regulations, including GMP, storage, and handling guidelines.
Documents Required for Starting a Pharmaceutical Business in Poland
- Completed registration application forms
- Evidence of financial resources
- Business entity documents (articles of association, etc.)
- Proof of legal representation
- Certificates of competence for key personnel
- Quality assurance documentation
Benefits to Start a Pharmaceutical Business in Poland
Poland offers a multitude of advantages for establishing a pharmaceutical business, including:
- Poland’s pharmaceutical market is experiencing continuous growth due to the aging population and the rising need for advanced healthcare solutions, providing access to a lucrative market.
- With a well-educated workforce in the pharmaceutical sector, Poland has a strong foundation of skilled pharmacists and scientists, contributing to the industry’s success.
- Poland’s competitive advantage lies in its lower operating costs compared to Western European nations, making it an appealing choice for pharmaceutical manufacturing and distribution.
- The Polish government actively encourages innovation in the pharmaceutical industry by implementing programs and initiatives, creating an environment that fosters research and development.
Costs required to incorporate a Pharmaceutical Business in Poland
The cost required to incorporate a pharmaceutical business in Poland is:
- Registration fees
- Legal and administrative fees
- Licensing and authorization fees
- Translation costs
- Consultancy fees
Starting a pharmaceutical business in Poland offers a lucrative chance for international entrepreneurs and investors who want to enter a dynamic market with favourable regulations. By comprehending the registration procedure, complying with regulatory obligations, and utilizing the resources at hand, you can effectively navigate your way to success in Poland’s flourishing pharmaceutical industry.
Reach out to OnDemand International now to arrange a consultation and explore how we can assist you in effortlessly registering your pharmaceutical business in Poland.
The necessary documents include the company’s legal documents, tax identification, shareholder agreements, pharmaceutical permit, pharmaceutical wholesale permit, and GMP certificate.
The registration process can take up to two weeks.
CEIDG is a business book of entries with info on self-employed entrepreneurs. Any sole trader must register in CEIDG.
The available legal entities include a limited liability company, joint-stock company, sole proprietorship, and partnerships.