GMP recognition by MOH of Ukraine:

Recognition of certificate of compliance to Good Manufacturing Practice in Ukraine. How to avoid every batch quality control of medicines – GMP recognition certificate. Ukraine, Kiev, Cratia Ltd.

In accordance with the Order of Ministry of Health of Ukraine #391, October 30, 2002, starting from 01.09.2006 quality of all medicinal products that are being imported to the custom territory of Ukraine have to be assured by every batch control (quality assurance in state laboratory). That means that samples from every batch number imported to Ukraine have to be controlled by local state laboratory.

Up to the end of 2005 there were no such regulations regarding custom control, and quality assurance was performed randomizely. Quality assurance seriously increases the expenses: cost of the assurance per every batch is approximately from 500 to 1500 USD and takes 2-4 weeks.

The only way to prevent such expenses is a GMP-recognition procedure of the manufacturing site. Procedure is performed by State authority of medicinal products and medical devices of Ministry of Health of Ukraine . Certificate of recognition of compliance of the manufacturing site to requirements of good manufacturing practice is valid for 2 years from the moment of first registration, and for 5 years during renewal of registration.

Cratia Ltd. offer it's services on assistance in GMP-recognition for any interested manufacturer of the medicinal products.

GMP recognition procedure consists from two parts: first is adoption of the dossier and second is visit of the inspector to the manufacturing site. Recognition of the manufacturing sites that are situated in the PIC/S countries do not require second part – visit of the inspector. PIC/S manufacturers are being adopted only by expertise of the site dossier that usually takes approximately 20 days from the moment of submission of the dossier.

All other countries follow the standard procedure that include inspection of the manufacturing site by authorized state inspector from Ukraine .

List of PIC/S countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, United Kingdom (source: http://www.picscheme.org/ ).

all necessary consulting and correspondence;
translation of the received documents to the Ukrainian language, additional work on the dossier;
submission of the dossier and cover letters to State Agency of medicinal products and medical devices;
accompanying the dossier during recognition process, defending interests of Customer;
assistance in management of the visit of State inspector (for non-PIC/S countries);
all other expenses; service fee defrays all charges required for regcognition except State fees;

Recognition of certificate of compliance to Good Manufacturing Practice in Ukraine. How to avoid every batch quality control of medicines – GMP recognition certificate. Ukraine, Kiev, Cratia Ltd.

Average term to prepare the dossier upon received documentation from manufacturer (translation, preparation of the cover letters) – approximately 2 weeks ;

For manufacturers from PIC/S certificate of recognition of the GMP compliance is issued after adoption of the documents. Other countries will be visited by inspector:

preparation to inspection (plan of the trip, plan of inspection) – app. 2 weeks;
inspection – from 3 to 5 days;
preparation of the report upon inspection – app. 2 weeks;

for manufacturers from PIC/S – app. 1,5 months;
for all other countries – app. 3 months;

Price of Cratia Ltd. service is app. 2000 EURO; depend on the characteristics of the manufacturer and documentation.

State fees are currently not required, but manufacturer must submit all confirmations about payments for transportation, hotel, food and accompanying.

Following list of documents is required for evaluation of the procedure of recognition of certificate of compliance to good manufacturing practice:

7. Copy of the last GMP-control report issued by state authority in the manufacturer's country.

8. Manufacturing license of the site(s) that mentioned in application (if applicable).

Order of MOH of Ukraine № 391 dated 30.10.2002 “About order of certification of manufacturing sites of medicinal products”.

That Order is the main legal act that regulates procedure of the recognition of the compliance of the manufacturing site to requirements of the good manufacturing practice (GMP).

Recognition of certificate of compliance to Good Manufacturing Practice in Ukraine. How to avoid every batch quality control of medicines – GMP recognition certificate. Ukraine, Kiev, Cratia Ltd.