GOOD LABORATORY PRACTICE - eu- · PDF fileGOOD LABORATORY PRACTICE REPUBLIC OF SERBIA Bilateral screening: Chapter 1 – Free Movement of Goods

GOOD LABORATORY PRACTICE

REPUBLIC OF SERBIA Bilateral screening: Chapter 1 – Free Movement of Goods

Content

• Current legal framework

• Law enforcement

• Competence

• Administrative capacity

• GLP sertificate

• Future activities

Republic of Serbia - Bilateral screening Chapter 1 – Free Movement of Goods

• Law on Medicines and Medical Devices ("Official Gazette of the Republic of Serbia" No. 30/10) comply with Directive 2003/63/EC am. 2001/83/EC.

• Good Laboratory Practice Guidelines ("Official Gazette of the Republic of Serbia" No. 28/08), comply with directives 2004/9/EC and 2004/10 / EC.

• Rulebook on the entry, content of the application and the costs of entry in the Register of laboratories that perform laboratory testing ("Official Gazette of the Republic of Serbia" No. 4/11)

• Rulebook on the Good Laboratoy Practice Certificate form, information entered into the Register of the issued certificates, and keeping the Register ("Official Gazette of the Republic of Serbia" No. 100/11)


National regulations

History of GLP

• Good laboratory practice for medical product in medicine (Official Gazette of the FRY "No. 40/98)

• It has regulated only the area of preclinical trials of medicines.


Law on Medicines and Medical Devices

• Regulates: – Marketing authorization of medicines/medical devices for

human and veterinary use – Medicines pricing – Clinical trials – Pre-clinical trials under Good Laboratory Practice Guidelines – Medicines /medical devices production – Issuing of GMP/GLP certificate – Medicines /medical devices distribution – Pharmacovigilance/vigilance – Labeling of medicines/medical devices – Advertising medicines/medical devices – Inspections


Law enforcement


Law of Medicines and Medical

Devices

GLP Other

Ministry of health -Inspector for medicines and

medical devices

Ministry of Agriculture and environmental

protection

Medicines and Medical

Devices Agency of Serbia

Law

Article 94 regulate that the:

Preclinical testing of medicines, safety testing of the substances contained in medicinal product, pesticide, cosmetics, food additives, feed additives, and industrial chemicals is performed in accordance with the Guidelines of Good Laboratory Practice.

Also, bioavailability and bioequivalence laboratory testing in the process of clinical trials of medicines carried out in accordance with the guidelines of Good Laboratory Practice.


Law

Test results are used in the procedures obtaining marketing authorization of medicines, as well as the administrative procedures determined for placing pesticides, cosmetics or similar products, food additives, feed additives, chemicals, according to special laws that govern placing on the market these products consists, on the market .


Test results


TEST RESULTS

Ministry of Health

Medicines and medical devices Agency of Serbia

Ministry of Agriculture and enviromental protection

FOOD ADDITIVES COSMETICS

LICENCE FOR MEDICIN (FOR HUMAN AND VETERINARY USE)

Dir.2003/63/EC am.2001/83/EC

Department of

chemicals

Plant Protection Directorate

Veterinary Directorat

FEED ADDITIVES

CHEMICALS

BIOCIDES Reg. 1907/2006 & 1272/2008,

528/2012

PESTICIDES Reg. 1107/2009

Register

Article 94, Law:

Laboratories which performs laboratory testing according to GLP Guidelines, are obliged to report this activity to the Ministry of Health.

The Ministry of Health maintains a register of laboratories.


Rulebook

Registration is done on a form - Application for registration of laboratories that perform laboratory testing in the Register.

The application form is an integral part of the Rulebook on the entry, content of the application and the costs of entry in the Register of laboratories that perform laboratory testing ("Official Gazette of the Republic of Serbia" No. 4/11)

This regulation prescribes the manner of entry, the contents of the application and the cost of entry in the register of laboratories that perform laboratory testing.


GLP laboratories

Currently only one laboratory in Serbia is recorded in register of GLP laboratories: Institute of Virology, Vaccines and Serum „TORLAK“ laboratory, which is a medical product manufacturer as well.

“Torlak” has reported preclinical drug – vaccine testing, toxicity and immunogenicity.

They have completed only one study, in the pre-clinical vaccine testing, whole virus, from whose production they have given up.


Competence

Inspection of putting Law, GLP Guidelines and Rulebooks, into effect, directed to GLP, is perfomed by the Ministry of Health through inspectors for medicines and medical devices (Law: Article 208 – 216).

Inspector must have university degree (Pharmaceutical or Medical faculty), at least 3 years relevant professional experience and a successfully passed examination for work in ministry (Law:Article 209) .


Organization structure

Ministry of Health is organised in accordance with the Law on Ministries.

• Ministry of Health has 7 sectors.

Part of Sector for inspection affairs is Department for inspection of medicines and medical devices which has two units:

In accordance with the organization chart of the Ministry of Health

• head of department monitor and supervise the work of inspectors and

• the work of department is under the control of the Assistant Minister.


Organization chart of Sector for inspection affairs


SECTOR FOR INSPECTIONS AFFAIRS

DEPARTMENT FOR SANITARY INSPECTION

DEPARTMENT FOR HEALTH INSPECTION DEPARTMENT FOR

INSPECTION FOR MEDICINES AND

MEDICAL DEVICES

UNIT FOR PRODUCTION OF MEDICINES AND MEDICAL DEVICES, PREPARATION OF

GALENIC MEDICINES

- GLP Inspectors

UNIT FOR DISTRIBUTION AND SALE, GCP

DEPARTMENT FOR NARCOTICS AND

PRECUSORS

Inspectors


Department INSPECTORS

6 Pharmacists

GLP +

GMP, MD, Galenic medicines

Distribution Pharmacies, medical shops,

GCP Advertising

Inspectors

Number of inspectors Currently: six inspectors employed on a full-time basis,

pharmacists. According to existing internial organisation in Ministry of

Health: • For GLP inspection: 4 inspectors are dedicated (including

Head of department). They are also perfoming GMP inspection, medical devices

manufacturers, Galenic laboratoryes. • For inspection of wholselers (incl.APIs), pharmacies,

med.devices shops, GCP inspection, advertising : 2 inspectors are dedicated.


Traning of inspectors

A seminar designed for all inspectors was held in March 2011. in Belgrade, as a part of the project: Risk Management of Chemicals in Serbia, implemented by the Chemicals Agency (currently: Ministry of Agriculture and environmental. protection) in cooperation with the Swedish Chemicals Agency (KEMI), financed by The Swedish International Development Cooperation Agency (SIDA).

In the same year in June, organized one study, two-day training for inspectors in Sweden, Malmo.

Laboratory: Toxicon and HUSEC AB (she was in the process of

applying, still did not work).


Procedure

Department for inspection for medicines and medical devices has SOP for regulating activities of inspectors to monitor GLP Compliance with guidelines of GLP. Plan for the inspection of laboratoty and checking their

compliance with the GLP being prepared at the end of the current year for the next year in accordance with Article 116 of the Law.

Regular control of laboratory is provided every 2 years in accordance with the Law.


Inspection

INSPECTION

BY REQUEST OF

THE LABORATORY EX OFFICIO

CONTROL OF

COMPLAINTS

WITH

GLP

GUIDELINES

- certificate

REGULAR

Annual plan

EXTRAORDINARY

Compliance

SPECIAL

AT THE

REQUEST OF

OTHER

INSTITUTIONS


Procedure

Befor of inspection inspector prepares a plan and farward it to the laboratory.

Carry out inspection in the laboratory.

After performed inspection inspectors prepare report.


Inspection report

Containt of the report: • Report number and date of inspection • Name of inspector(s) • Name and adress of inspecedlaboratory, place of inspection • Purpose and scope of inspection • Reference to inspection • Names of responsible persons met during the inspection • Date, scope and findings of previous inspection • Description of activities during the inspection • Inspector‘s findings and observations • Conclusion with recommendations that have to be carry out • Signature(s) of inspectors(s) and signature(s) of responsible

person(s). Inspectors take measures, if necessary, in accordance with the Law.


Inspection report

In accordance with Article 113 of the Law, after the inspection the inspector is obliged to prepare a report on the compliance with GLP Guidelines which has to be submitted to the laboratory within 30 days.

Regarding to the report a laboratory can make comments or suggestions to removal deficiencies within 15 days.

After the evaluation the proposal or objections, inspector writes the final report with the conclusion on the compliance.

Based on the final report, the Ministry may issues a certificate of conformity with GLP Guidelines.


GLP certificate

At the request of the laboratory Ministry of Health issues the Certificate of compliance with Good Laboratory Practice, for a period of 2 years, Article 115 of the Law.

The sertificate is issued based on the request the laboratory, performed inspection and final report.

The certificate is signed by the Minister of Health. The Ministry shall keep a register of issued certificates.

Current situation: The register is empty because of there were no request for the issuance of GLP certificate.


GLP sertificate

• The content of form GLP certificate, data to be entered in the register of certificates issued and the manner of keeping the register are defined in the Rulebook.

• The form of certificates is an integral part of this Rulebook.


GLP sertificate

• CERTIFICATE OF GOOD LABORATORY PRACTICE

• Number of certificates:

• Date:

• Is confirmed:

• Business name and address of the laboratory:

• which is entered in Register of laboratories that perform laboratory testing under no .............,

• perform the following types of laboratory tests:

• Types of laboratory testing (e.g. Physical, chemical, toxicological, etc. :)

• in accordance with the Guidelines of Good Laboratory Practice ("RS Official Gazette", No. 28/08)

• This certificate is issued for a term of two years and shall be valid until ...... years.

Seal MINISTER

---------------------


List of expers

• In accordance with Article 112 of the Law, Minister of Health determines the experts who can participate in the process of conformity with the GLP Guidelines.

• Experts from the list of experts for the process of determining compliance can participate in determining the conformation only in the presence of inspectors.

• Formation of the list is in the process.


Planned activities in the future

Continuous monitoring of European legislation in this area, Transposition of EU legislation in this area in the national

regulations, In the existing regulations incorporate the terms "member

state", introduce the principles mutual recognition, Inspectors need practical training in the field of GLP, The training program outside of Serbia depends on the budget of Ministry of Health .



Thank you for your attention

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GOOD LABORATORY PRACTICE - eu- · PDF fileGOOD LABORATORY PRACTICE REPUBLIC OF SERBIA Bilateral screening: Chapter 1 – Free Movement of Goods