Legal Document

Title: Prakas No. 364 on the Implementation of Visas for and Registration of Medicinces
Type: Regulation
Issuing Agency: Ministry of Health
Responsible Agency: Ministry of Health
Issuing Date: 26-10-1994

 

UNOFFICAL TRANSLATION

 

KINGDOM OF CAMBODIA

Nation Religion King

 

Ministry of Health  

No. 364 សនឱ

 

PRAKAS

ON

THE IMPLEMENTATION OF VISAS FOR AND REGISTRATION OF

MEDICINES

 

 

Pursuant to:


The Minister of Health

 

The Constitution of the Kingdom of Cambodia;

Royal Decree of His Majesty Preah Bat Samdech Norodom Sihanouk Varman, King of the Kingdom of Cambodia, dated November 1, 1993, on the Establishment of the Royal Government of Cambodia;

Subdecree No. 44 S.E., dated August 10, 1994, of the Royal Government of Cambodia on Visas for and Registration of Medicines;

 

Hereby decides

 

Article 1:

The creation of visas for and registration of medicines aims to control the production, import, export and trading of medicines in  the Kingdom of Cambodia in order to ensure the quality of medicines and the production rights of manufacturers.

 

Article 2:

Visas for and registration of medicines, which  are  of  equal importance, are authorizations  for trading on the market  (Autorisation de mise sur le marché) for medicines for which visas have been acquired  and registration of  medicines from the Ministry of Health.

 

Article 3:

Visas for and registration of medicines are valid for five years from the date of issuance of the visas for and registration of medicines. Three months before expiration, the person concerned shall complete papers to apply for the renewal of the visas for and registration of medicines to the Ministry of Health in accordance with the conditions defined in article 6 or 7.

 

Article 4:

Medicines shall be appropriately packaged according to the defined conditions:

-  On the outer box or bottle shall appear the name of the medicine, its international name, level - excipients - quality of treatment (indication), contraindication (contre indication), dosage and usage ... label (vignette), stating value of AMM, expiry date ... etc.;

-   There  shall  be  a  description  of  the  medicines  inside  ( Notice  ou prospectus) ;

-  On the strip or bottle or   tube of   the medicine,   there shall   be additional specifications of the lot number and expiry date;

- For a medicine comprising a poisonous substance, there shall be a special label and note: "sale with prescription ".

 

Article 5:

Poisonous substance (substance véneneuse) refers to a substance that can cause serious or secondary danger or addiction or damage to the nervous system.

 

Article 6:

Medicines manufactured locally can be displayed for sale only if there are approval visas from the Ministry of Health. To apply for medicine visas, one shall complete the following documents:

-   Applica tion for medicine visa (sample available)

-   Summary characteristics of the medicine (Resumé des caracteristiques du produit )

-   Pharmaceutical document (Document pharmaceulique)

-     Surrunary pharmacology document (Document pharmacologique en resumé)

-   Surrunary toxicology document (Document toxicologique en resumé)

-   Summary clinic document (Document clinique)

-   Ten samples of medicine (Echantillon medical)

-   Receipt of visa fees at 100 US dollars for each set of documents.

 

Article 7:

Medicines imported from abroad can be displayed for sale only if there is approval of registration from the Ministry of Health. To apply for registration of medicine, the following documents shall be completed:

-   Application for registration of medicine (sample available)

-   Certificate of the manufacturing capacity and ability of the manufacturing country in accordance with the conditions determined by the World Health Organization (Certificat B.P.F.)

-   Certificate of authorization for trading on the market of the manufacturing country (Certificat A.M.M.)

-   Certificate of authorization for trading on the market of other countries (if any)

-   Summary characteristics of the medicine (Resume des caractéristiques du produit )

-   Pharmaceutical document (Document pharmaceulique)

-   Summary pharmacology document (Document pharmacologique en resumé)

-   Summary toxicology document (Document toxicologique en resumé)

-   Summary clinic document (Document clinique)

-   Ten samples of medicine

-   Receipt of registration fee payment (100 US dollars) for each set of documents.

 

Article 8:

Medicine made of one or more active ingredients, which is officinal (Officinales) stated in the pharmacopeia (Plinn11ncopeeof France, England, Japan, America, Europe may be exempted from completion of documents of the medicine's pharmacology, and clinic toxicology.

 

Article 9:  

The request for registration of traditional medicines imported from abroad shall be subject to completion of the following documents:

-  Application for registration of medicine, sample available

-    Certificate of authorization for trading on the market of the manufacturing country (Certificat A.M .M .)

-  Summary characteristics of the medicine (Resume des caracfiristiques du produit )

-  Pharmaceutical document

-  Clinic document

-  Ten samples of medicine

-     Receipt  of  registration  fees  (100  US  dollars)  for  each  set  of documents.

 

Article 10:  

A request for visas for traditional medicines produced locally shall be subject to completion of the following documents:

- Application for medicine visas (sample available)

-  Summary characteristics of the medicine ( Resume des caracfiristiques du produit )

- Pharmaceutical document

- Clinic document

- Ten medicine samples

-  Receipt of visa fees (50 US dollars) for each set of documents.

 

Article 11:    

Technical documents shall be written in Khmer, French or English.

 

Article 12:

If necessary, the person concerned shall provide additional documents or reagents required for analysis as per the request of the national laboratory.

 

Article 13: 

The medicines for medical and pharmaceutical research study (not for sale) can be exempted from the request for registration of medicine.

 

Article 14:

Medicines of different dosage (Dosage), galenical forms (Forme galenique) or different manufacturers shall have different visas, registrations of medicines.

 

Article 15:  

In case there is any modification, whether [great or] small, to the excipients or presentation, the person concerned shall request prior authorization from the Ministry of Health before s/he can put [the medicine] on sale, by paying a fee of 50 dollars per set of documents for such modification.

 

Article 16:    

The Minishy of Health has the righ t to reject the applica tion for visas for or regisb·a tions of medicines for those medicines which:

-    The Ministry of Health has found to be of little or no importance for preventing or treating any disease, or to be potentially harmful to the health of users;

-    The manufacturing country has issued a ban for use in the manufacturing country;

-    Have inaccurate or fraudulent technical documents   (Inexact  ou frauduleux).

In  case  of  rejection,  the  fees  for  visas  for  and  registrations  of medicines will not be reimbursed to the person concerned.

 

Article 17:

The Ministry of Health is entitled to postpone or revoke visas for and registrations of medicines for those medicines which:

- Are harmful to the health of users;

- Are subject to quality-related accusation from the local or overseas competent ministry;

- Are banned by the manufacturing country for use; 

- Have inaccurate or fraudulent sample documents.

 

Article 18:

Medicines which are displayed on sale without visas for and registrations of medicines or improperly as per the exhibits shall be classified into ones secretly produced or illegally imported, and the offender shall be punished according to the laws in force.

 

Article 19:

The Inspectorate-General of the Ministry of Health and the Department of Medicines and Supply shall give instructions, monitor and inspect the implementation of this prakas as per their respective duties.

 

Article 20:

This prakas shall take legal effect from the date of signature onwards.

 

 

Phnom Penh Capital, October 26, 1994

Minister of Health

(Signature and stamp)

 

Dr. CHHEA THAING

 

 

CC:

- Cabinet of the National Assembly

- Cabinet of the First Prime Minister

- Cabinet of the Second Prime Minister

- Ministry of Justice

- Ministry of Economy and Finance

- Ministry of Commerce

- Ministry of Information

- Cabinet of the Ministry of Health

- Inspectorate-General of the Ministry of Health

- Capital-Provincial-City Department of Health

- Department of Medicines and Supply

- Pharmaceutical Factory

- Pharmaceutical Import-Export Company

- Pharmacies, sub-pharmacies, traditional medicine dispensaries

- Records