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Establishing a pharmaceutical company in Germany

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Pharmaceutical is one of the most developed segment of the German economy. It is not surprising, that entrepreneurs, wishing to start entrepreneurial activities in the pharmaceutical field, consider registering a pharmaceutical company in Germany a promising solution.

You can learn more about opening a German firm for pharmaceutical activities by contacting IQ Decision experts for legal advice on registering a company in Germany.

The assessment of directions in the pharmaceutical business

Before starting a pharmaceutical business in Germany, it is necessary to study carefully the market and evaluate all possible options for business development. The final choice, in general, will depend on goals and a size of the budget, for example, you can sell medicines under the brand of your company, or you can obtain a license for the production of medicines in Germany as a self-sufficient/independent entrepreneur. There is the option of joining forces with an existing medicine manufacturer.

Types of pharmaceutical companies:
  • Pharmaceutical importing companies;
  • Pharmaceutical export firms;
  • Special pharmaceutical enterprises;
  • Pharmaceutical distribution companies;
  • Pharmaceutical manufacturers;
  • Pharmaceutical marketing organizations.

It is worth noting, that this decision will require significant investment and an extensive package of permits, including obtaining a license to manufacture medicines in Germany. Therefore, having a limited budget, it would be optimal to think about starting a pharmaceutical distribution business. And after the company stabilizes and begins to develop in this niche, it will be possible to expand its activities and engage in the production of medicines.

The legal framework for the sale of pharmaceutical products in Germany

So, it is necessary to highlight laws, governing a pharmaceutical activity in Germany. The most important are the following:

  • a Social code;
  • a Medicines Act;
  • a Drug Pricing Act;
  • a Pharmacies Act;
  • the Act on the economic optimization of pharmaceutical care.
Registering a German commercial firm for pharmaceutical activities

Obtaining a German pharmaceutical license is a rather complicated procedure, it is advisable to seek legal advice on establishing a pharmaceutical business in Germany. A preliminary list of documents:

  • a business plan;
  • the description of the future company and its activities;
  • a Charter;
  • documents, confirming the information on shareholders (if a joint-stock company is chosen as the organizational legal form);
  • other documents, collected individually.
A procedure for registering a German pharmaceutical company
  • First, you need to draw up a detailed business plan and choose a name for the future company;
  • To choose brand names for products;
  • To define a logo design;
  • To register a trademark in Germany and take care of a trademark protection;
  • To obtain a license to sell medicines in Germany;
  • To issue a license for the production of medicines in Germany (for manufacturing companies);
  • To get a tax identification number for the company;
  • To find suppliers (for non-manufacturing companies);
  • To take care of product packaging;
  • To start a production of medicines (for a manufacturing company).
Assistance in developing a business plan for a pharmaceutical company

A detailed commercial plan helps to identify those moments of the business, that were not initially paid due attention to. Qualified lawyers of our company will provide recommendations on the preparation of a business plan for a pharmaceutical company. A well-formed plan helps identify priority tasks and directions, where the funds will go, as well as highlight areas, where funding can wait. Also, during the preparation of the business plan, it is determined which licenses must be obtained to set up a pharmaceutical company in Germany, and in which particular government institution this will happen.

Also, this plan will help determine what production facilities, machines and laboratory equipment, as well as personnel and accessories are required for the work of a pharmaceutical firm. We must not forget, that the production will require a stable supply of water and electricity, as well as high-quality ventilation equipment.

It is worth noting, that the business plan should, also, cover other key aspects, such as financing, goals, competitive analysis, operating costs and marketing costs.

Read also:

A launch of the pharmaceutical production in Germany

The entrepreneur will be required to do the following:
  • to find a land for industrial buildings;
  • to build/rent buildings or premises;
  • to establish a heating, ventilation and air conditioning system;
  • to establish water/electricity supply systems;
  • to establish the supply of compressed air;
  • to provide laboratories with necessary equipment;
  • to take care of the proper quality of interior decoration and equipment installation;
  • to allocate funds for formalities and licensing for the pharmaceutical business;
  • to complete other requirements.
  • it will also be necessary to allocate liquid assets to:
  • a salary to staff;
  • a repair and maintenance of equipment/premises;
  • a lease (if necessary);
  • the promotion/marketing;
  • other expenses.

The accurate costing will help you seamlessly set up a pharmaceutical manufacturing company in Germany. A production company needs to promote its product, it will require investments or the involvement of a separate marketing company.

Opening a German pharmaceutical distribution company

Material investments in the registration of a non-manufacturing pharmaceutical company are less in comparison with a manufacturing company. A distribution company requires less floor space as well as less staff, but the advertising budget may be higher.

You will need to organize the following:
  • A building/office space, that needs to be properly decorated;
  • Furniture and accessories;
  • Office equipment (computers, printers, etc.);
  • To obtain licenses and permits;
  • Liquid assets:
  • for staff salaries;
  • for rental premises (if required);
  • for promotion.
Obtaining a pharmaceutical license in Germany

After registering in German Register, you should apply for pharmaceutical permits in Germany. A licensing process is regulated by the Medicines Act and involves a very strict procedure. The best solution in this case is to turn to experienced IQ Decision lawyers, who will provide personal advice on obtaining licenses for the pharmaceutical business.

Read also:
Trademark registration and intellectual property protection in Germany

Starting a pharmaceutical business, you must be prepared to wage serious competition with large industry companies with a well-known reputation. For this reason, it is important to research the market, and invest in promoting your product.

The logo and image of the brand, as well as the website of the company should be thought out to the smallest detail. If possible, you can hire a team of people, who would be engaged in marketing and brand promotion.

A fierce competition in the industry, as well as disputes regarding the use of certain names for medicines, require the adoption of measures to protect intellectual property, to protect trademarks and logos. All this becomes especially relevant, when it is necessary to protect a unique solution or formula. To register a trademark, a patent, other type of intellectual property in Germany, you must apply for registration of TM in DPMA (German Office for Trademarks and Patents).

You can find out a detailed information regarding these issues from IQ Decision experts during the legal consultation on the registration of trademarks in Germany.

A final word

Innovative pharmaceuticals can have a ripple effect on the market, until they become known worldwide.

For everything to succeed, you will have to make great efforts, carefully plan your actions, research the market, protect intellectual property. And in all this, and also in many other things, IQ Decision lawyers are ready to help you.

Please note, that all the above material is provided for informational purposes only, and is not a consultation. If you have questions, related to registering the pharmaceutical business in Germany, there is an opportunity to analyze possible solutions together with IQ Decision experts during personal legal advice on pharmaceutical activities.

In addition, our lawyers accompany clients at all stages of company registration in Germany or Europe, and other parts of the world, are ready to assist in opening of a corporate account in a German bank or obtaining a permit for pharmaceutical activities, provide other legal services.

  • The information outlined in the article is actual at the time of its publication.

  • Please refer to our specialists for checking possible solutions for your business.

  • Still have any questions?

    Fill out the form or contact us as you find convenient: skype, telegram, etc. Our experts will help you resolve the issue.

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