responsibility finder
Schleswig-Holstein

Show retail sale of non-prescription medicines

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

If you wish to trade in over-the-counter medicines, you do not require a license; all you need to do is register with the competent authority.

All companies in which over-the-counter medicines are manufactured, stored, packaged or placed on the market are subject to supervision by the competent authorities.

The competent authority must ensure that the relevant legal standards are observed. This is carried out by means of regular unannounced inspections for which a fee is charged or inspections on an ad hoc basis.

The facilities, companies or other persons have a far-reaching obligation to tolerate and cooperate. If they do not comply with the statutory regulations, the competent authority can initiate appropriate measures in accordance with the Medicinal Products Act.

This includes verbal or written orders to prevent or eliminate deficiencies, and violations can also be punished as an administrative offense with a warning, warning fine, fine or as a criminal offense.


Process flow
  • As a rule, you can register trade in over-the-counter medicinal products with the competent authority by e-mail or in writing by post.
  • Further information on the procedure can be found on the websites of the competent authorities.
Who should I contact?

Please contact the public health department of your district or city.

Competent authority

The health authorities of the districts and independent cities are responsible.

Requirements

Proof of expertise

Over-the-counter medicines may be sold outside pharmacies provided that the person operating the business, the legal representative or the person responsible for the management or sale of the over-the-counter medicines has the necessary expertise and can provide proof of this.

A competent person must be present at each business premises and must also be present during normal sales hours so that qualified advice and proper sales can be guaranteed. If this is not possible, the medicinal products must be suitably withdrawn from the customer's access and sale for the duration of the absence of the competent person (e.g. via lockable shelf cabinets).

The details of the scope and proof of expertise are regulated. The expertise includes knowledge and skills regarding the proper filling, packaging, labeling, storage and placing on the market of medicinal products that are approved for sale outside pharmacies and knowledge of the regulations applicable to these medicinal products.

Expertise is not required when placing finished medicinal products on the retail market that may be dispensed in tourist traffic, that are used to prevent pregnancy or sexually transmitted diseases in humans or certain disinfectants that are intended exclusively for external use or oxygen in oxygen cylinders.

The required expertise can be demonstrated either by a corresponding examination, by examination certificates for relevant professional training or in some other way.

The examination certificates for the specializations

  • pharmacy
  • chemistry
  • biology
  • human or veterinary medicine

from universities as well as the professional training

  • to become a trainee pharmacist
  • as a pharmaceutical-technical assistant
  • to become a druggist
  • to become a pharmaceutical engineer
  • to become a pharmacy assistant
  • to become a pharmacy assistant
  • to become a pharmaceutical and commercial assistant

are recognized as proof of competence.

Which documents are required?
  • Completed notification form
  • Certificate of competence or comparable professional qualification
What are the fees?

Fee: 50,00 - 4000,00 EUR
Payment in advance: No
https://www.gesetze-rechtsprechung.sh.juris.de/perma?j=VwGebV_SH
The competent authorities charge fees for - the confirmation of notifications (50 to 2000 euros) - the monitoring of establishments (50 to 4000 euros) - sampling (50 to 1000 euros) - measures (20 to 4000 euros)

What deadlines do I have to pay attention to?

You must register the sale before starting the activity.

Processing duration

There are no statutory processing deadlines.

Legal basis
Appeal

You can appeal against the fee notices.

What else should I know?

Trade in over-the-counter medicines outside of pharmacies is not subject to authorization.

Some tips on handling medicines

Stocks of medicines must be stored in accordance with the regulations and the manufacturer's storage instructions must be observed. Over-the-counter medicines are usually stored at room temperature (15-25 degrees Celsius). Document compliance with the prescribed temperature. Protect the medicines from direct sunlight or indirect heat. In addition, you should avoid storing medicines next to odorous products, perishable foods or on the floor. The expiry date ("use by ...") must be strictly observed.

Author

The text was automatically translated based on the German content.

Technically approved by

Ministry of Justice and Health of the State of Schleswig-Holstein

Professionally released on

13.07.2023

Process flow

  • As a rule, you can register trade in over-the-counter medicinal products with the competent authority by e-mail or in writing by post.
  • Further information on the procedure can be found on the websites of the competent authorities.

Who should I contact?

Please contact the public health department of your district or city.

Competent authority

The health authorities of the districts and independent cities are responsible.

Requirements

Proof of expertise

Over-the-counter medicines may be sold outside pharmacies provided that the person operating the business, the legal representative or the person responsible for the management or sale of the over-the-counter medicines has the necessary expertise and can provide proof of this.

A competent person must be present at each business premises and must also be present during normal sales hours so that qualified advice and proper sales can be guaranteed. If this is not possible, the medicinal products must be suitably withdrawn from the customer's access and sale for the duration of the absence of the competent person (e.g. via lockable shelf cabinets).

The details of the scope and proof of expertise are regulated. The expertise includes knowledge and skills regarding the proper filling, packaging, labeling, storage and placing on the market of medicinal products that are approved for sale outside pharmacies and knowledge of the regulations applicable to these medicinal products.

Expertise is not required when placing finished medicinal products on the retail market that may be dispensed in tourist traffic, that are used to prevent pregnancy or sexually transmitted diseases in humans or certain disinfectants that are intended exclusively for external use or oxygen in oxygen cylinders.

The required expertise can be demonstrated either by a corresponding examination, by examination certificates for relevant professional training or in some other way.

The examination certificates for the specializations

  • pharmacy
  • chemistry
  • biology
  • human or veterinary medicine

from universities as well as the professional training

  • to become a trainee pharmacist
  • as a pharmaceutical-technical assistant
  • to become a druggist
  • to become a pharmaceutical engineer
  • to become a pharmacy assistant
  • to become a pharmacy assistant
  • to become a pharmaceutical and commercial assistant

are recognized as proof of competence.

Which documents are required?

  • Completed notification form
  • Certificate of competence or comparable professional qualification

What are the fees?

Fee: 50,00 - 4000,00 EUR
Payment in advance: No
https://www.gesetze-rechtsprechung.sh.juris.de/perma?j=VwGebV_SH
The competent authorities charge fees for - the confirmation of notifications (50 to 2000 euros) - the monitoring of establishments (50 to 4000 euros) - sampling (50 to 1000 euros) - measures (20 to 4000 euros)

What deadlines do I have to pay attention to?

You must register the sale before starting the activity.

Processing duration

There are no statutory processing deadlines.

Legal basis

Appeal

You can appeal against the fee notices.

What else should I know?

Trade in over-the-counter medicines outside of pharmacies is not subject to authorization.

Some tips on handling medicines

Stocks of medicines must be stored in accordance with the regulations and the manufacturer's storage instructions must be observed. Over-the-counter medicines are usually stored at room temperature (15-25 degrees Celsius). Document compliance with the prescribed temperature. Protect the medicines from direct sunlight or indirect heat. In addition, you should avoid storing medicines next to odorous products, perishable foods or on the floor. The expiry date ("use by ...") must be strictly observed.

Author

The text was automatically translated based on the German content.

Technically approved by

Ministry of Justice and Health of the State of Schleswig-Holstein

Professionally released on

13.07.2023

Further information and offers