How to get Russian GMP certifcate?
9 August 2016 Ministry of Industry and Trade published guideline “How to get Russian certificate about good manufacturing practice (GMP) in Russian Federation.#1714.
Procedure of getting Russian GMP certificate.
The authority responsible for getting of Russian GMP certificate is Ministry of Industry and Trade. (Department of development of medical and pharmaceutical industry).
Expert organization performing inspection – Institute of Medicines and Good Practices (FGBU).
Contacts: Kitaygorodskiy proeszd 7
Cell phone: +7 8 495 539 21 87
During procedure you can get number of your application and Name of expert responsible for your application.
List of documentation needed for getting Russian GMP certificate:
- Application
- Kit of documentation:
– Power of Attorney
– Site master File
– Information about detected incompliances, recalls identified during last 2 years.
– List of Medicines which is produced on your manufacturing site.
– Manufacturing License.
– Letter of agreement for performing GMP inspection.
Each Manufacturing site (each address you need to provide distinct application.
Inspection is mandatory for receiving Russian GMP inspection.
State fee – 7500 rubles app. 110 $)
Payment for inspection performing by Institute of Medicines and Good Practices (FGBU) is calculating in accordance to “Guidleine about payment for GMP inspection” (Приказом Министерства промышленности и торговли Российской Федерации от 11.01.2016 № 9 Об утверждении методики определения размера платы за оказание услуги по инспектированию GMP) and could be up to 2,8 mln. rubles (app 45 k$ depending on currency rate) depending on inspection program, expert expense etc. Culculation performing by Institute of Medicines and Good Practices (FGBU).
Procedure step by step for getting Russian GMP certificate.
- Submission of application to Ministry of Industry and Trade.
- Checking of an application for correctness (10 business days)
- Issue of Letter of deficiency (if needed). Applicant must replay in 20 business day deadline. (otherwise – rejection of an application).
- Decision about performing of Inspection. (after that docs is sent to Institute of Medicines and Good Practices (FGBU)).
5. Inspection for receiving of Russian GMP certificate is performed by Institute of Medicines and Good Practices (FGBU).
In 20 business days after decision about performing of GMP inspection Institute of Medicines and Good Practices (FGBU) includes manufacturing site in Inspection Schedule, which is published here: Calendar of planned Russian GMP inspections
Updates of schedule is performed during 3 business day’s from its changing.
Inspection should be performed during 160 business days from Decision about performing of Inspection of Ministry of Industry and Trade.
Inspection itself should be performed in 10 business days deadline.
After inclusion of manufacturing site in inspection schedule applicant should make an agreement with Institute of Medicines and Good Practices (FGBU) and pay fee for inspection during 20 business days deadline from signing of agreement.
After inspection report should be created in 30 business day’s deadline by Institute of Medicines and Good Practices (FGBU) and sent in 3 days deadline to Ministry of Industry and trade and to applicant.
6. GMP certifcate should be issued in 10 business days deadline from signing of expert report by Institute of Medicines and Good Practices (FGBU).
GMP certficate should be created in accordance to Приказом Министерства промышленности и торговли Российской Федерации от 04.02.2016 № 261 Об утверждении форм заявления о выдаче заключения о соответствии производителя GMP
Russian GMP certificate is valid for 3 years (from end of Inspection).