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Procedure descriptions

Applying for an operating licence for a public pharmacy

If you want to run a pharmacy, you need a licence from the competent authority. You can apply for a licence for your individual pharmacy or your main pharmacy and up to three branch pharmacies.

The licence is issued to you personally and for specific premises. The licence obliges you to personally manage a pharmacy under your own responsibility. If you wish to operate several public pharmacies, you must personally manage main pharmacy and appoint a pharmacist as the person responsible for each additional branch pharmacy. The responsible person must fulfil the same obligations as set out in the Pharmacy Act and the Pharmacy Operating Regulations for Pharmacy Managers. Several persons can only operate a pharmacy in the legal form of a partnership under civil law (GbR) or a general partnership (OHG); each partner then requires a separate licence to operate the pharmacy.

In the case of a new establishment or relocation, an acceptance inspection is carried out by the competent authority as part of the procedure.

Responsible authority

The regional council responsible for the registered office of the pharmacy

Regierungspräsidium Stuttgart

Details

Prerequisite

You

have a German licence to practise as a pharmacist and
the necessary reliability . A person is reliable if he or she can guarantee that he or she will continue to practise his or her profession properly. This depends on an assessment of the facts in each individual case. The responsible Chamber of Pharmacists is therefore asked by the regional councils for an opinion on reliability.
have full legal capacity,
declare on oath that they have not entered into any legal transactions or agreements that violate certain provisions of the Pharmacy Act.
submit other contracts relating to the establishment and operation of the pharmacy at the request of the competent authority,
prove that they have the necessary premises,
are medically fit to manage a pharmacy and
state whether and at what location in another EU/EEA state you operate one or more pharmacies.

licence may only be granted to licensedapplicant not passed the pharmaceutical examination in the Federal Republic of Germany after a total training period of five years ( ) if the application is for a pharmacy that has been in operation for at least three years.

This does not apply to licensed whose formal qualifications have already been recognised by the competent authorities for other purposes and who have actually and lawfully exercised the professional activities of pharmacistin Germany for at least three years without interruption.

Procedure

You can apply for a pharmacy licence electronically or in writing. Your application must contain the following information:

Residential address
Telephone number where you can be reached during the day
Name of the pharmacy, street, postcode and town
Date of the planned opening or takeover

The required documents listed below must be attached to the application.

Deadlines

The documents should be submitted to the competent authority at nine weeks before the date of the planned takeover, opening or relocation of the pharmacy(ies).

Once the requested operating licence has been granted, a pharmacy may only be opened after the competent authority has certified that the pharmacy meets the legal requirements . In the case of new openings, the date for the acceptance inspection must be arranged 14 days in advance.

The licence expires, among other things, if it has not been used within one year.

Required documents

Depending on the form in which you wish to operate the pharmacy, you will need to submit different documents.

New establishment or purchase of a pharmacy

short tabular curriculum vitae stating the country in which you studied pharmacy and passed the pharmaceutical examination, and precise details of your professional activities after obtaining your licence to practise.
You must sign and date the curriculum vitae by hand.
Proof of identitye.g a certified copy of your passport or identity card
current official certificate of good conduct for submission to an authority, this must be sent directly to the regional council )
current medical certificate ( older than three months and must bear the doctor's stamp aThe certificate must that you are not medically unfit to manage a pharmacy properly.
A certified photocopy of your licence to practise, and, if applicable, proof of a change of name by means of a registry office certificate
an affidavit to be submitted after conclusion of the contracts:
You affirm that you have not entered into any legal transactions or agreements that violate the Pharmacy Act. You can make the affidavit before a notary or the licensing authority.
Declarations and assurances:
- the existence of full legal capacity and whether criminal or professional proceedings were or are pending
- whether you have applied for a further operating licence in the Federal Republic of Germany
- Information on whether and, if applicable, where you operate one or more pharmacies in a member state of the European Union or in another contracting state of the Agreement on the European Economic Area or in a contracting state to which Germany and the European Union have contractually granted a corresponding legal entitlement
- Exclusion of third-party and multiple ownership in the Federal Republic of Germany
- on the complete submission of all contracts and agreements relating to the establishment and operation of the pharmacy
- to confirm the completeness and accuracy of the information
Proof that you have the necessary premises:
- officially certified extract from the land register or other proof of ownership of the pharmacy property
- Purchase or rental agreement
- Site plan of the property with exact location parcel of land
- scaled plan of the business premises with details of the square metre sizes, their use and furnishings; if possible, furnishing plan at a scale of 1:50 in duplicate.
- List of the floor space of the operating rooms, this must be (110 square metres
- Declaration as to whether the pharmacy is barrier-free accessible
- for existing pharmacies: the above-mentioned evidence, apart from the purchase or rental agreement, if there have been changes to the existing documents
The competent authority may request further documentsfor example
- Purchase contract for the pharmacy in the original or as a certified photocopy
- Notarised photocopy of proof of change of name
- Waiver by the previous owner of the operating licence issued to him/her and return of the licence certificate to the competent authority
- GbR or OHG contract
- Renunciation of the operating licence already granted to the applicant and return of the previous licence certificate to the competent authority
- Proof of financing, for example ( including agreements on collateral provided, proof of equity

Lease of a pharmacy

the documents for the new establishment or purchase of a pharmacy with the exception of point 8, items 1 to 3
Lease agreement
if the pharmacy was already leased: waiver by the previous tenant for the operating licence granted
in cases of inheritance: Proof of inheritance as proof of authorisation to lease

Management of a pharmacy

the documents for the new establishment or purchase of a pharmacy with the exception of items 6 and 8 points 1 to 6
Proof of inheritance
Management contract

Branch pharmacies,

Ask the responsible regional council which documents you need. The relevant applications and information are published on the homepage of the regional councils.

For each branch pharmacy, the operator must appoint a responsible person in writing who must fulfil the obligations set out in the Pharmacy Act and the Pharmacy Operating Regulations for Pharmacy Managers. The licence certificates must be submitted by the designated responsible person in a current certified copy and, if applicable, proof of the change of name by means of a registry office certificate as well as the employment contracts in a certified copy or original duplicate ). The main pharmacy must be expressly named.

Costs

The fees are based on the state fee schedule in accordance with fee item 10.

Miscellaneous

The supply of medicines to nursing homes and hospitals by pharmacies requires a supply contract between the nursing home or hospital operators and the pharmacy operators. This contract must be authorised by the regional council. Standard model contracts for care home and hospital supply are available from the specialised pharmacy publishers.

The following applies to the supply of hospices and specialised outpatient palliative care facilities by pharmacies:

Pharmacy operators must notify the responsible regional council in writing (by post or email) of agreements on the supply of emergency stocks of narcotics and a review of emergency stocks at least every six months prior to the first supply in accordance with Section 5d (1) No. 3 BtMVV.