Healthcare

2. Getting Licenses

a) How to establish a hospital

 

Step 1 

 

1. In line with the relevant zoning legislation, the private healthcare area usage decision taken by the municipality must be provided.
2. A report prepared by the authority (Municipality or Directorate of Environmental Health Research) empowered by the Governorate demonstrating that the zoning area is neither subject to noise, air and water pollution nor close to the industrial enterprises and the non-sanitary enterprises which may have adverse effects on human health. 
3. A report prepared by the Provincial Traffic Commission or Transportation Coordination Center under the Municipality demonstrating that the zoning area is both convenient and accessible in terms of transportation conditions and points.
4. A report prepared by the Municipality demonstrating that the size of the area allocated for parking lots is satisfactory in that it meets the size specified in the Car Park Regulations.
5. A report prepared by the Municipality demonstrating that the size of the green area allocated for the hospital building is satisfactory.

 

Step 2 

 

1. A preliminary permit must be obtained from the Ministry of Health. 
2. Regarding the projects for which the preliminary permit is issued, construction works must start within 3 months. 
3. Following the inspection conducted by the Provincial Directorate of Health, a report must be written indicating that the construction works started. 
4. Construction works must be completed within 3 years and an operation permit must be obtained. 
 

Step 3 

 

As for the buildings which have been constructed in line with the legislation and obtained a hospital or private health facility occupancy permit, following documents are required:

 

1. A document obtained from the Directorate of Fire Brigade demonstrating that necessary precautions against a possible fire outbreak are taken 
2. Original or notarized copy of the Commercial Registry Gazette specifying the capital position and partners of the company if the private hospital is to be founded by a company or the notarized foundation voucher if the private hospital is to be established by a foundation
3. Earthquake resistance report prepared by the building audit companies or universities
4. A joint technical report prepared collectively by the Provincial Directorate of Health and Provincial Directorate of Public Works and Settlement specifying the building standards
5. A report prepared via an on-site inspection of all medical units, by a team of experts in the branches of medicine to be organized by the Provincial Health Director, demonstrating if the building incorporates sufficient medical equipment 
6. Medical Waste Agreement prepared by the Municipality and Medical Waste Report prepared by the Provincial Directorate of Environment

 

Step 4

 

1. Letter for preliminary permit is sent from the Provincial Directorate of Health to the Ministry of Health approximately in 10 days. (The 10-day time frame specified in this entry is not included in the Private Hospitals Regulation and considered to be stemming from practice)
2. Time period set for the start of the construction works is 3 months following the issue of the preliminary permit and the time period specified for the completion of the construction works together with the hospital is 3 years. (Periods set for the commencement and completion of the construction works indicated in this entry have also been mentioned under “Step 2” above; therefore, the above entry is a repetition of the content of the “Step 2”).
3. Full completion of the hospital construction is followed the phase of licensing and the issue of the operation permit. In this phase, gathering of the commission members, obtaining the public works reports and sending the document to Ankara for licensing take approximately 3 months. 
4. Reapplication to the Provincial Directorate of Health and Ministry of Health is required in order to obtain an operation permit; application period for the operation permit is approximately 3 months. (As per the 6th paragraph of Article 15 of the Private Hospitals Regulation, a private hospital must receive its operation permit and start admitting and treating patients within six months as of the date on which it obtained license from the Ministry).

 
b) Medicine production

 

Information and conditions essential in terms of the production places where medicines, active substances in medicines and intermediate products are produced 

 

1. Documents belonging to the managing director of the production place:

 

  • Social security premium documents and a statement by the employer demonstrating that the managing director has at least two years of applied experience in activities related to product quality analyses as well as quantitative analyses and controls of the active substances within one or more enterprises having a production place permit
  • A letter demonstrating that the managing director accepts to assume the relevant duties and responsibilities
  • A notarized copy of diploma or the original of the university leaving certificate with a photograph
  • A copy of the birth certificate certified within the last six months
  • Bill of health and eye examination report obtained within the last six months
  • A signed and dated curriculum vitae
  • Two passport-size photographs
  • Chamber registration certificate to be obtained from the trade association, of which he/she is a member
  • Criminal record obtained within the last six months
  • A document demonstrating that all relations with the previous working place are severed (if any)
  • Other documents demonstrating experience

 

2. Documents belonging to the production manager(s):

 

  • A notarized copy of diploma or the original of the university leaving certificate with a photograph
  • A signed and dated curriculum vitae
  • Other documents regarding the professional experience

 

3. Documents belonging to the quality control manager:

 

  • A notarized copy of diploma or the original of the university leaving certificate with a photograph
  • A signed and dated curriculum vitae
  • Other documents regarding the professional experience

 

4. Documents belonging to the quality assurance manager and/or quality assurance team:

 

  • A signed and dated curriculum vitae
  • A notarized copy of diploma or the original of the university leaving form with a photograph
  • Other documents regarding the professional experience
  • In case of working with a team, names of the persons who are members of the team together with the information and documents concerning their educational statuses and experiences

 

5. Following information related to the production place:

 

  • Full address
  • Its position in the city plan, if any
  • Building plan and layout plan
  • Sketches of production flow charts (its ventilation class will be specified on the sketch)
  • Information related to the activities carried out in the production storage facility:
  • Production scope (medicine included in the scope of the medicinal products for human use, products labeled as intermediate products, blood and blood products, radiopharmaceuticals, medical gas and medical and surgical materials, etc.)
  • Pharmaceutical forms produced: Tablet, film-coated tablet, sugar-coated tablet, capsule, micropellet capsule, liquid and sterile products used internally or externally (ampoule, bottle, etc., sterilized in their final container, ampoule, bottle, powder, etc., which are not sterilized in their final container)
  • Medical products which should be produced in separated places (hormones, penicillin, cephalosporin, medicines for cancer, insecticides used through application on the human skin)
  • Products manufactured, analyzed, etc. through contract manufacturing
  • Activities such as production, analysis, etc., carried out through contract manufacturing (notarized copy of the bilateral agreement must be submitted).


6. All standard operation modes regulating the activities (production, quality control, storage, cleaning, validation, etc.) carried out in the production place
7. A list of the machines, equipment and tools related to the activities such as production, quality control, etc.
8. Features of the water and ventilation system together with its sketch
9. The original and notarized copy of the non-sanitary enterprise license
10. Environmental Impact Assessment (EIA) report (refer to the EIA report for this dossier) 
11. Fee receipts

 

Following the arrangement of all these documents and obtaining of the permit for the production plant, a dossier should be prepared in accordance with the preliminary review-application formats of the Common Technical Document (CTD) available on the official web site of the General Directorate of Medicine and Pharmacy (www.iegm.gov.tr) and an application should be made to the Ministry of Health. Arrangement of license takes approximately 210 days.

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