Legal Document

UNOFFICAL TRANSLATION

KINGDOM OF CAMBODIA

NATION-RELIGION-KING

MINISTRY OF HEALTH

No. 003អបស/ឱអបស

Phnom Penh date: 8^th - January – 2013                                                                              

Prakas

On

Procedures and Conditions of the Submission of the registration of

Pharmaceutical Manufacturer from Oversea

Ministry of Health Ministry

- Having seen the constitution of the Kingdom of Cambodia

- Having seen the Royal Degree No. នស/រកត/0913/ dated September 24, 2013 regarding about the appointment of the Royal Government of Cambodia

- Having seen Royal Kram នស/រកម/1096/06 dated January 24, 1996 promulgating the law on the establishment of the Ministry of Health

- Having seen Royal Kram នស/រកម ​0696/02 dated June 17, 1996 promulgating the law on drug management.

- Having seen Royal Kram នស/រកម1207/037 dated December 28, 2007 regarding about the amendment of the law on drug management.

- Having seen Sub-Degree No. 67 អនក្រ/បក dated October 22, 1997 regarding about organizing and functioning of the Ministry of Health

- Having seen Sub-Degree No. 44 អនក្រ dated August 10, 1994 regarding about visa and drug lists.

- Having seen the join-declaration No. 993 សហវប្រក dated December 28, 2012 regarding about the public service provision of the Ministry of Health

- Having seen the declaration No. 364សនឱ dated October 26, 1994 regarding about the implementation of visa and drug lists

- Reference the necessary requirement of the Ministry of Health

Decision:

Article 1:        The purpose of the registration of pharmaceutical manufacturers is to receive the correct information provided by pharmaceutical manufacturers about the good manufacturing practice situation in drug production to ensure that the drug productions are high quality agreeing to the international standard.

Article 2:        Drug Import export companies and representative offices shall firstly be registered of pharmaceutical manufacturers just being approved to be registered of Drug productions in the Ministry of Health.

Article 3:        The submission for the registration of pharmaceutical manufacturers shall compose of the following documents:

-Application form submits for the registration of pharmaceutical manufactures.

-Administrative documents (appendix 1).

-Technical documents (appendix 2)

Article 4:        The certificate of good manufacturing practice shall be validated in the periods at least 06 months when placing documents and with the conditions below:

1. Original files certified by the royal ambassador or general counselor of the Kingdom of Cambodia to any country or

2. Copied files certified by the royal ambassador or general counselor of the Kingdom of Cambodia to any country followed by original files for double check or

3.Copied files certified by the royal ambassador or general counselor of the Kingdom of Cambodia to any country and attaching with the certificate of completed pharmaceutical manufacturers registration in any country in Asia or other country that the copied files are certified by competent authorities of that country or

4.Certificate of completed pharmaceutical manufacturers registration in any country in European Union, United States of American, Australia, Japan as the copied files certified by royal ambassador or general consul of the Kingdom of Cambodia to any country or

5. Copied files of the recognized assessment by WTO (WTO prequalification) certified by royal ambassador or general counselor of the Kingdom of Cambodia to any country.

Article 5:        In case of pharmaceutical manufacturers have different address; they shall be registered with every address.

Article 6:        Certificate of pharmaceutical manufactures registration is valid within 05 years. Before expiration 06 months, the titular shall fill documents to renew the validity of the certificate of pharmaceutical manufacturers registration as set forth in article 3.

Article 7:        The Ministry of Health shall not provide the certificate of pharmaceutical manufacturers registration in case of:

-Wrong or fake documents.

-Pharmaceutical manufacturer’s name is same with the other one.

-Pharmaceutical manufacturers have only one location buy deferent names.

Article 8:        The Ministry of Health is entitled to withdraw or suspend the certificate of pharmaceutical manufacturers registration in the event that:

-It is accused on drug quality from local and international competent authorities.

-The original country has withdrawn or suspended the certificate of good manufacturing practice in drug production.

-Documents to register the pharmaceutical manufacturers are incorrect or fake.

-The titular is not following with the enforced laws of the Kingdom of Cambodia.

-Fail to provide the certificate of good manufacturing practice (GMP) on time as stated in article 6.

Article 9:        The fee for the certificate of pharmaceutical manufacturers registration is 4.800.000 Riels (four million eight hundred thousands).

Article 10:      The Ministry of Health is entitled to inspect the place of pharmaceutical manufacturers to certify of the good manufacturing practice of the pharmaceutical manufacturers.

Article 11:      The Director General for health, General Department of Inspection, and department of drugs and Food, have duties to inspect and instruct the implantations of this Prakas effectively.

Article 12:      Any provisions contrary to this Prakas will be considered as invalid.

Article 13:      This Prakas is valid from the signing date onward

Received places:

-General secretariat of parliament

-Council minister

-Ministry of Justice

-Ministry of Communication with Parliament, Senate, and Inspection (for information)

-Ministry of Information (for information)

-Provincial and Municipal halls (for information and cooperation)

-As article 11

-Provincial and Municipal health departments

-Pharmaceutical manufacturers (for implementation)

-Documents kept