28 janvier 2017 - Emeran ATANGANA ETEME

Cameroon: DECREE No.2001/MINSANTE OF 22 NOVEMBER 2007 TO REGULATE THE PRODUCTION AND DISTRIBUTION OF FOOD SUPPLEMENTS IN CAMEROON

DECREE No.2001/MINSANTE OF 22 NOVEMBER 2007 TO REGULATE THE PRODUCTION AND DISTRIBUTION OF FOOD SUPPLEMENTS IN CAMEROON

THE MINISTER OF PUBLIC HEALTH

Mindful of the Constitution;

Mindful of Law No. 96/03 of 4 January 1996 to lay down the Outline Law in the domain of health;

Mindful of Decree No. 2002/209 of 19 August 2002 to organize the Ministry of Public Health;

Mindful of Decree No. 2004/320 of 8 December 2004 to organize the Government, all its subsequent amendments;

Mindful of Decree No. 2007/269 of 7 September 2007 to reshuffle the Government;

HEREBY DECREES AS FOLLOWS:
CHAPTER I: GENERAL PROVISIONS
Section 1 - This Decree regulates the production and distribution of food supplements in Cameroon.
Section 2 – Under this decree,
1) A food supplement shall mean any food presentation whose purpose is to supplement the normal diet and which is a concentrated source of nutrients or other substances with a nutritional or physiological effect alone or in combination. It is marketed in doses in the form of capsules, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquid or solid preparation intended to be taken in measured small quantities units;
2)A nutrient shall mean any chemical contained in foods or deriving from the digestion of food that the cells use directly in their metabolism;
3)A nutritional or physiological substance shall mean any chemically defined substance with nutritional or physiological properties recognized as such, except for substances with pharmacological properties only and nutrients;
4) Plants and plant preparation shall mean ingredients from plants or compounds isolated from them except the abovementioned substances with nutritional or physiological properties, excluding plants or preparations of plants with pharmacological properties and intended for therapeutic use only.
Section 3 .- Only nutrients and nutritional or physiological substances, plants and plant preparations, and other ingredients whose use in traditional human food is recognized in accordance with regulations in force, additives, flavourings and processing aids which are allowed for use in human feeding, shall be authorized for the manufacture of food supplements.

 

Section 4. Nutrients can be used in the manufacture of food supplements only if their use is authorized, if they meet the identity and purity criteria with the maximum levels required under the standards of the Codex Alimentarius.
Section 5 .- Nutritional or physiological substances are substances whose use is authorized by the Codex Alimentarius as food intended for human consumption, provided the daily intakes based on the directions of use do not exceed the reference intake.
Section 6 .- Only parts of plants and plants traditionally considered as foods, excluding their non-traditional preparations in human food, or plant preparations allowed by the instruments of the Minister of Public Health, can be used in manufacturing food supplements.

CHAPTER II:

LABELING AND ADVERTISING FOOD SUPPLEMENTS


SECTION I: LABELING

Section 7(1) The labeling of products identified under this Order shall conform to the national standards on labeling and, in addition, bear the following indications in English or French:

 

  • The marketing name clearly stating « food supplement »;
  • The names of the nutrients or substance categories that characterize the product or an indication on the nature of those nutrients or substances;
  • The recommended daily intake of the product;
  • A warning indicating that it is not advisable to exceed the recommended daily intake;
  • A statement to warn against the use of food supplements as a substitute for a balanced and varied diet;
  • A warning stating that the product must be kept out of reach of young children;
  • Storage conditions and in particular, the maximum storage temperature.

 

(2) Any mention on the label giving these products the property of preventing, treating or curing a human disease, or suggesting these properties, or any mention stating or implying that a balanced and varied diet is not a sufficient source of nutrients in general shall be prohibited.
Section 8 – (1) The quantity of nutrients or substances contained in the products shall be written on the label in digit form. It shall refer to the daily intake of product recommended by the manufacturer as indicated on the label.
(2) Reference values and information on vitamins and minerals shall equally be expressed in percentage.

 

Section 9 – (1) The declared values, indicated in Section 8 above, shall constitute average values that were calculated based on the manufacturer’s analysis of the product.

 

(2) The percentage of reference values for vitamins and minerals can also be shown graphically.

 

Section 10 – A decision by the Minister of Public Health shall lay down, where applicable, the procedures for implementing the labeling provisions.
SECTION II: ADVERTISING
Section 11. – Advertisement on food supplements shall in any way state or suggest their superiority over a varied and balanced diet and replace it.
Section 12. – (1) Any advertisement giving these products the property of preventing, treating or curing a human disease, or suggesting these properties shall be prohibited.

 

(2) Any representation or other illustration which may idealize food supplements shall be prohibited.
CHAPTER III: MARKETING

 

SECTION I:

MARKETING AUTHORISATION

 

Section 13 – Importation, sale or cutting of food supplements free of charge or for a fee in the Republic of Cameroon shall be subject to the prior authorization of the Minister of Public Health.
Section 14- The initial marketing authorisation of a food supplement on the national market shall be subject to the submission of a file including the following:

 

  • the importer or manufacturer’s application for an authorization written in English or French, stamped at the current rate, addressed to the Minister of Public Health through the Department of Health Promotion;
  • the manufacturer or importer’s identification form;
  • A sample of the label used for this product;
  • Documents and information to attest that the food supplement is legally manufactured or marketed in the country of production;
  • Presentation by the registrant of all data in his/her possession relevant to the assessment of the food supplement;
  • the importer or manufacturer’s tax record.

 

Section 15- The application addressed to the Minister of Public Health shall be forwarded together with:

 

  • two (2) information sheets per product;
  • a chemical, pharmaceutical and biological file in three (3) copies stating:

 

  • the origin and nature of raw materials;
  • the qualitative and quantitative composition;
  • the description of the manufacturing method;
  • the quality control of raw materials, intermediate products and of the finished product;
  • stability tests and shelf life of the finished product;
  • Evidence of the product indications.

 

  • A proof of probate fees payment;
  • the marketing authorization, or free sale certificate issued by the competent authority of the country of origin;
  • Five (5) sales samples in English and French, together with analysis reports in English andFrench of corresponding batches and of prospectors.

Section 16 – On the request of the Administration, any food supplement batch shall be subject to quality expertise at the expense of the distributor or manufacturer under the principle of sampling.
Section 17- A decision by the Minister of Public Health shall set the registration fee per product for a grant or renewal of the food supplements marketing authorisation.
Section 18 .- The registration fee shall be paid into an account opened by the Minister of Public Health upon delivery of a payment receipt to be attached to the application along with the list of products to be registered, indicating whether it is a grant or a renewal of license.

 

Section 19 - The authorization to market shall be issued on opinion of the Ministerial Committee for the approval of food supplements.
Section 20 – The authorization to market shall have a three-year validity period and any application for renewal shall be submitted not later than three (3) months prior to the expiry date.
Section 21 – The manufacturer or producer shall undertake to:

 

  • immediately inform the Minister of Public Health of the occurrence of side effects or accidents associated with the use of a food supplement after obtaining the marketing license;
  • inform the Minister of Public Health of any subsequent change undergone by the product in the manufacturing country within a maximum period of one month following the date of this change;
  • immediately withdraw from the Cameroonian market all products whose authorization to market were suspended or expired;
  • take full responsibility for any incident that could occur at the level of the protection of the concerned product patent.

SECTION II: THE APPROVAL COMMITTEE

Section 22(1) A Committee to approve food supplements shallbe set up within the Ministry of Public Health. It shall:

 

  • Examine the applications for approval for the marketing of dietary supplements in Cameroon;
  • Rule on the suspension or withdrawal of the marketing license of a dietary supplement.

 

(2) At the end of the files review, the Committee shall submit its evaluation report to the Minister of Public Health for the final decision.
Section 23 – (1) The Committee shall be composed as follows:

 

Chairperson: the Secretary General of the Ministry of Public Health;

Rapporteur: the Director of Health Promotion;

Members:

  • The Director of Pharmacy and Drugs;
  • The Director of National Laboratory of Drug Control;
  • The Representative of the Centre Pasteur in Cameroon;
  • One (1) representative of the Ministry of Agriculture;
  • One (1) representative of the Ministry of Industry, Mines and Technological Development.

Section 24 – A technical unit shall be set up within the Committee. It shall:

 

  • receive and record applications for approval;
  • examine applications for approval and make technical remarks;
  • forward the examined files to the Committee in prescribed timeframe;
  • keep a record of approvals.

Section25 – The Technical Unit shall comprise:

 

Chairperson: The Sub-Director of Food and Nutrition;

Technical Secretary: The Service Head of Food Quality Control;

Members:

  • The Sub-Director of Drugs in the Department of Pharmacy and Drugs;
  • The Service Head of Dietetics and nutrition interventions;
  • The Bureau Head of Food Hygiene Promotion;
  • The Bureau Head of Food Standards and Control;
  • TheBureau Head of Dietetics.

Section26 – Apart from pharmacies, the opening and functioning of any institution specializing in the distribution of such products shall be subject to a statement.
Section27 – The statement referred to in Section 26 above shall be backed up by:

 

  • A comprehensive list of products to be marketed;
  • A duly completed information sheet per product;
  • A copy of each product’s marketing license.

 

Section28 .- In any case, the Minister of Public Health shall have the right to prohibit or maintain the marketing of these products, and their distribution free of charge or for a fee by the said institutions in case of:

 

  • The presence of substances giving them the properties of drugs for reason of their nature or their dosage;
  • the presence of toxic substances;
  • contamination by pathogenic organisms;
  • presentation that does not guarantee product quality;
  • manipulation in conditions that present a risk to consumer health;

 

Section29 – The decree shall come into force only after review of the information sheet of each product to be marketed and the sanitary inspection by the Technical Services of the Department of Health Promotion.

 

CHAPTER V: MISCELLANEOUS AND FINAL PROVISIONS
Section30 – The importation for marketing and the possession of food supplements that do not conform to the provisions of this Decree in order to sell or distribute them for free shall be prohibited.
Section31 – No person shall possess food supplements in order to sell them if they are not a specialist in food and nutrition, in pharmacy or a health personnel with an experience in the field of nutrition.

 

Section 32. – Producers or distributors of concerned products shall have six (6) months from the date of signature of this Decree to comply with the new regulations.
Section33 – Unexpected controls shall be done as need arises, in relevant structures, possibly with sample-taking for testing.Inspection and testing costs shall be borne by the controlled structure.
Section34 .- The Director of Health Promotion and the Director of Pharmacy and Drugs shall, each in his own sphere, be responsible for the implementation of this Decree which shall be recorded and published, according to the emergency procedure and inserted in the Official Gazette in English and French. /

 

 

 

 

 

 

 

 

 

 

DECREE No. 967/MINSANTE/MINCOMMERCE OF 25 JUNE 2007 ON THE MEDICAL MARKING OF TOBACCO PRODUCTS PACKAGES

THE MINISTER OF PUBLIC HEALTH
Mindful of the Constitution;

Mindful of Law No. 64/LF/23 of 13 November 1984 to protect public health;

Mindful of Decree No. 92/031 of 10 August 1990 to govern commercial activity in Cameroon;

Mindful of Law No. 2005/0056 of 27 July 2005 to grant the President of the Republic the authorization to ratify the Framework Convention of the World Health Organization on tobacco control signed in Geneva on 21 May 2003;

Mindful of Decree No. 2002/209 of 19 August 2002 to organize the Ministry of Public Health;
Mindful of Decree No. 2004/320 of 8 December 2004 to organize the Government;

Mindful of Decree No. 2005/089 of 29 March 2005 to organize the Ministry of Commerce;

Mindful of Decree No. 2005/440 bis of 31 October 2005 to ratify the Framework Convention of the World Health Organization on Tobacco Control signed in Geneva on 21 May, 2003;

Mindful of Decree No. 93/720/PM of 22 November 1993 to lay down the procedures of Decree No. 90/031 of 10 August 1990 to govern commercial activity in Cameroon

HEREBY DECREES AS FOLLOWS:
Section1: The marking of packages, cartons, boxes or other packaging of tobacco products marketed in Cameroon shall be mandatory.
Section2: The mandatory marking of packages, cartons, boxes or other packaging shall be designed to warn consumers of tobacco products on the serious health risks they are putting themselves and people close to them.
Section3: All packages, cartons, boxes or other packaging of tobacco products in Cameroon sold for payment or free of charge, must carry information indicating the level of nicotine and tar, and the following notices in English and French written in a clear, visible and legible manner.

 

LE TABAC NUIT GRAVEMENT A LA SANTE DU FUMEUR ET DE CELLE DE SON ENTOURAGE »

« TOBACCO SERIOUSLY DAMAGES YOUR HEALTH AND THAT OF PERSONS CLOSE TO YOU »

“VENTE EN CEMAC”  “FOR SALE IN CEMAC”
Section4: The notices referred to in Section 3 above shall be printed in bold capital letters, minimum size of 16 points, covering at least 50% of the main sides, in black writing on white background and contrasting with the color of the package, box, carton or any other package.

Section5: Similar messages adopted in foreign countries and approved by the Minister of Public Health of Cameroon shall be accepted for all products imported regularly.

Section6: Manufacturers, importers, distributors and sellers of tobacco products based in Cameroon shall have six (06) months from the date of signature of this Decree to comply with these regulations.

Section7: (1) Any package, carton, box or other package of tobacco products that shall not bear the notices and characters identified in Sections 3 and 4 above shall be seized and destroyed in the interest of public health by judicial police officers assisted by sworn trade officers.
(2) Any seizure and destruction operation non-compliant with the provisions set forth by this Decree shall be written in a report and sent to the Prosecutor with territorial jurisdiction within fifteen (15) days. A copy shall be sent to the Minister of Public Health and to the Minister of Trade.

Section8: Any person contravening the provisions of this Decree shall face the penalties prescribed by the regulations in force, without prejudice to prosecution for dangerous activities, in accordance with Sections 74 and 228 of the Penal Code.
Section9 All previous provisions repugnant hereto, in particular those of Decree No. 0016/A/MINDIC/MSP/CAB of 8 June 1999 on the medical marking of packages of tobacco products are hereby repealed.
Section10: This Decree shall be registered, published according to the procedure urgency and inserted in the Official Gazette in English and French. /-

 

Yaounde, 25 June 2007

 

                                              
Urbain OLANGUENA AWONO                           Luc Magloire MBARGA ATANGA

 

MINISTER OF HEALTH                                     MINISTER OF COMMERCE

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