UAE Healthcare / Pharma LawCabinet Resolution No. (21) of 2018 Regulating the Marketing of Infant and Young Child Feeding Products

Article (1) Definitions In the application of the provisions hereof, the following words and expressions shall bear the meanings assigned thereto respectively, unless the context otherwise requires: State : The United Arab Emirates. Ministry : The Ministry of Health and Prevention. Minister : The Minister of Health and Prevention.

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 2 The Competent Health Authority : The Ministry or any government body, federal or local, concerned with health affairs in the State. Healthcare System : Government or private bodies or organizations working directly or indirectly in health care and awareness, including nursery schools and child-care institutions. Concerned Body : Any government body, federal or local, related to the application of the provisions hereof. Healthcare Facility : A facility duly licensed to carry out medical examination, offer medical consultation or assistance in the diagnosis of diseases, treatment, nursing, admission for treatment or any act related to treatment or rehabilitation, whether owned or managed by a natural or legal person, including the healthcare facilities affiliated to the State schools of medicine if they provide any of the services referred to in this definition. Breastfeeding : Breastfeeding a baby either directly from the breast to the Baby’s mouth or indirectly by sucking the mother’s milk from the breast and then giving it to the baby. Infant : The child from birth up to the age of 12 months. Young Child : A child from the age of 12 months up to the age of 24 months. Formula Feeding : Feeding the Baby or the Infant with any formula as a total or partial substitute for breast milk. Infant Formula : Milk or any milk-like product of animal or vegetable origin, industrially formulated in accordance with the standards applicable in the State, and marketed or otherwise presented as being suitable for satisfying the nutritional needs of infants as a total or partial substitute for feeding infants. Follow-up Formula : Milk or any milk-like product of animal or vegetable origin, formulated industrially in accordance with the standards applicable in the State, for satisfying the nutritional needs of infants above six months and young children. Complementary Food : Any food marketed or presented as an addition to breast milk, infant

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 3 formulas or Follow-up Formulas. Feeding Devices : Feeding bottles, nipples and pacifiers. Product : The Infant Formulas, Follow-up Formulas, Complementary Food and Feeding Devices. Health Worker : Any person works in the Healthcare System, paid or unpaid. Package : Any means for preparing or packaging the Product, wholly or partially, to be commercialized as an independent unit. Label : Any descriptions, picture, figure or any other mark; written, printed, sketched, marked, decorated, stamped, glued or otherwise fixed on the Package identifying the Product, including any document or information enclosed with the product. Promotion : Any direct or indirect means for inducing a person to buy or use the Product, including the use of any form of publication or publicity, be it audio, print, visual or electronic...etc, with the intent of promoting, commercializing or selling the product in an direct or indirect manner. Marketing : Commercializing, distributing, selling and advertising the Product by all means. Provider : Supplier, distributer, manufactured or any natural or legal person having a license to practice any activity relating the Product Marketing. Batch : A specific amount of the Product made using the same approaches and under the exact conditions. Sample : An individual or small quantity of the Product made available for free. Logo : Picture, symbol or any other form identifying the Provider or the Product.

Article (5) All forms of information and educational materials regarding the Product shall: 1. Contain only accurate, updated and scientifically-backed information. 2. Not include any picture, phrase, symbol, sign or means encouraging formula feeding or the use of feeding bottles or undermining the importance Breastfeeding. In act contrary to this clause shall be prohibited. 3. Be written in Arabic. Any other language may be added provided that the content matches the Arabic version. 4. Not directly or indirectly claim or suggest that the Product is equivalent to, comparable with or superior to breast milk or Breastfeeding. 5. Not contain the brand name, trademark or logo of the Provider. 6. Point out that Breastfeeding is the optimal and best source for feeding infants and young children.

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 5 7. Contain detailed illustration of the following: a. The benefits and superiority of Breastfeeding. b. The benefit of exclusive Breastfeeding during the first six months of the infant life and the importance of continued breastfeeding for two years. c. The importance of introducing commentary foods from the age of six months. d. Why it is difficult to reverse the decision to stop breastfeeding. e. The negative effects on Breastfeeding due to the partial introduction of formula feeding, in case of the improper use of any product. 8. Any other conditions set by the Minister.

Article (6) 1. The Provider may provide the Health Workers with any information and educational materials subject to the following: a. The content thereof is in conformity with Articles 4 and 5 hereof. b. They are restricted to scientific and factual data pertaining to the technical aspects and how to use the Product. c. They are void of any direct or indirect indication that formula feeding is the same as or superior to Breastfeeding. 2. The Health Workers may be provided with the sources of approved studies supporting the relationship between the Product set forth herein or its components and the health, growth and development of infants and young children, provided that such sources are based on credible and approved studies in the manner determined by a Ministerial Resolution to be issued in this regard.

Article (7) Label Requirements Without prejudice to the statutes and mandatory standards approved by the State, a Label shall meet the following requirements: 1. Contains clear and easy-to-read data which is not, in any way misleading or deceptive and cannot be erased or removed from the Label. 2. Is affixed onto the Product Package in a manner that does not allow its separation or removal.

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 6 3. All information provided therein must be written in Arabic. Any other language may be added provided that the text content matches the Arabic version. 4. The Label must contain detailed information about the following: a. Instructions on the preparation methods and the proper use of the Product. b. The age during or beyond which the Product is recommended, to be written in numbers. c. The health risks resulting from improper preparation and from early use of the Product prior to the recommended age. d. The components used in the Product manufacturing together with identifying the source and type of milk or similar products. e. The data and information relating to the Product and its components which must conform to the mandatory standards approved by the State. f. Name and address of the Provider. g. Batch number of the Product, manufacturing date and expiration date. h. Clarifying the climatic conditions and storage conditions suitable for storing the Product. i. Defining the time period during which the Product may be used after opening its package. 5. Any other conditions or controls imposed under a Ministerial Resolution.

Article (8) In addition to the data referred to under Article (7) hereof, the label of the Infant Formulas and the Follow- up Formulas shall contain the following: 1. A statement underlining that Breastfeeding is best. Breast milk is the ideal food the healthy growth and development of infants and young children. It protects against Diarrhea and other diseases. This statement must be written in a clear and prominent manner. 2. Warning note pinpointing that it is important to seek a medical advice before deciding to use feeding formulas or Follow-up Formulas, as a partial or total substitute for Breastfeeding, and highlighting the importance to carefully follow the preparation instructions and use a cup instead of the bottle. 3. Warning note on the health risks with respect to the improper preparation, storage and usage of the Product and on using the Product before the recommended age. 4. A statement stressing the importance of not using Follow-up Formulas for infants of less than six

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 7 months of age. 5. Inclusion of feeding timetable within the preparation instructions. 6. Information on the protein source.

Article (9) Label data referred to in Articles (7) and (8) hereof shall not contain: 1. Names, symbols, marks or images violating the State’s public order and morale. 2. Images, drawings or figures of infants or mothers or other images or texts going beyond the intent of clarifying the preparation method, or conveying a direct or indirect message that the Product is ideal or encourage its use for infants or young children. 3. Health or nutritional claims suggesting a relation between the Product or its components and health preservation or suggesting any physiological role by the Product elements in the growth and development of the natural functionalities of the body, unless it is required for a specific product according to the statutes in force in the State. 4. Statements indicating that the Product is comparable to breast milk or discouraging the Breastfeeding.

Article (10) Requirements of the Feeding Devices As to the Feeding Devices, the following requirements shall be satisfied: 1. To conform to the statutes and mandatory standards approved by the State. 2. To provide in their Labels the terms and conditions provided for herein, particularly: a. The statements to be defined by a Ministerial Resolution shall be written in capital letters on the Label and Package. b. Methods of preparation and use along with guidelines on their cleaning and sterilization shall be included. c. To explain how to feed the infant and young child using ordinary utensils like a cup. d. To mention the health risks concomitant with bottle-feeding or improper preparation.

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Article (11) Product Registration 1. Prior to its marketing in the State, the Product shall be registered in the Ministry by the Provider. 2. The Provider who has the product to be marketed in the State shall register whatever is remaining thereof in his possession immediately upon the issuance of the present Resolution and shall adjust its affairs in accordance therewith according to the procedures and within the period set by the Minister by virtue of the resolutions to be issued in this end. 3. Having ascertained its satisfaction to all conditions and requirements set forth herein and its compliance to the standards adopted by the State, a registration certificate shall be granted to the Product. 4. Without prejudice to the period to be set by virtue of a Ministerial resolution and referred to under Clause (2) of this Article, no product shall be marketed in the State unless it has been registered at the Ministry.

Article (12) Duties of the Competent Health Authorities and the Healthcare System The Competent Health Authorities and the Healthcare System, each within its respective powers, shall take the procedures required for the implementation of the present Resolution, including the following: 1. Encouraging and protecting Breastfeeding, providing Health Workers with information and guidelines which promote their efficiency and improve their performance and making sure that the Health Workers know and are well aware of all information required, particularly, that disclosed under Articles (4), (5) & (6) of the present Resolution. 2. Training Health Workers to help mothers to start and continue Breastfeeding and to overcome any direct or indirect practices, which may hinder or delay the same. 3. Encouraging mothers to breastfeed their babies till the age of two years. 4. Preventing the display of the Products subject matter hereof, or any posters or signs relating thereto inside the Healthcare Facilities. 5. Providing necessary advices and guidelines regarding the importance of Breastfeeding and its effective role in both the mother’s and child’s health.

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Article (13) Promotion The Provider, its delegate or any person whose activity would have an impact on the Product Marketing procedures shall not: 1. Use discount facilities such as special offers, discount vouchers, installments, offering awards, gifts or other promotional means including linking the sale of the Product with any other goods to make use of the reduced price. 2. Offer one or more free samples of the Product. 3. Give away or distribute informational or educational materials or arrange educational events relating to the Product if it doesn’t satisfy the requirements provided herein. 4. Hold any educational or work programs or events which would promote the Product or the Provider. 5. Give or supply the Health Workers or any entity affiliated to the Healthcare System with a quantity of the Product at a price less than the announced wholesale price, if any, or at less than 80% of the retail price in case of not having announced wholesale price. 6. Supply the Healthcare System facilities with equipment, services or any stationary or publicity materials bearing a name, logo, figure, trademark or any description designating the Provider. 7. Offer or grant any awards, gifts or financial aids to the Health Worker or health workers unions specialized in mother and child health, including scholarships, search grants or funds for holding or attending meetings, seminars, continuing education courses or conferences. 8. Sponsor the activities, competitions and telephone consults or campaigns on reproductive health, pregnancy, delivery or infant and young child feeding or any related subjects.

Article (14) Obligations Incumbent Upon the Health Worker The Health Worker shall not: 1. Prescribe any product, unless necessary provided that he shall individually teach the mother, family members or any childcarer the methods of its use. In such case, health risks concomitant with its use or its unnecessary or improper use, shall be explained.

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 10 2. Accept any gifts or material or immaterial rewards given directly or indirectly by the Provider or its delegate. 3. Accept any samples of the Product, the equipment or tools used in the preparation or use thereof. 4. Give any sample of the Product to pregnant women, mothers, or family members of infants and young children. 5. Accept aids for the purpose of arranging or attending conferences, seminars or workshops. 6. Perform any activity against the objectives and content of the present Resolution.

Article (15) Administrative Penalties 1. Without prejudice to any penalty imposed or procedures taken by the entity that caught the violation pursuant to the relevant statutes, the hereinafter administrative penalties shall apply in case of failure to register the Product; or failure to meet the labels, educational information or Feeding Devices requirements stated herein; or in case of violation of the provisions of Articles (13) and (14) hereof: a. Warning. b. Depriving the violator from marketing the Product for a period not more than one year. The Product may be recalled from markets at the expense of the violator, if necessary. c. Revoking the Product Registration Certificate. d. Charging the violator with all the expenses and costs incurred to remove and remedy the damages ensued from the violation committed thereby upon its failure to do remove or remedy such damages. 2. The Competent Health Authority shall impose the penalties referred to under Clause (1) of this Article on the violating facilities falling within the scope of its powers, except for the penalty invalidating the Product Registration Certificate which shall be imposed by the Ministry. 3. The Ministry shall be notified of the violations recorded and procedures taken in their regard by the bodies concerned and the Competent Health Authorities. The respective supporting documents and the penalties imposed shall be attached to such notification. 4. Having been advised of the violations according to Clause (3) of this Article, the Ministry shall verify that no other violations were committed by the same violator in another emirate of the State. If the

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Cabinet Resolution of 2018 Regulating the Marketing of Infant and Young Child Feeding Products 11 violation commission is established, the Ministry shall take the necessary procedures in this regard and impose the penalties referred to under this Article.