Prior Authorisation for Advertisement of Pharmaceutical Products and Products Claiming Health Benefits

1. What is the legislation governing pharmaceutical product advertising?

In Macao, the legislation governing pharmaceutical product advertising is Decree-Law no. 30/95/M dated 10th July. In addition, Decree-Law no.7/89/M dated 4th September also applies to pharmaceutical product advertising.

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2. What is the legislation governing the advertisement of products claiming health benefits?

In Macao, the legislation governing the above advertisement is Decree-Law no. 7/89/M dated 4th September.

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3. What are “pharmaceutical products”?

According to paragraph b) of article 2 of Decree-Law no. 30/95/M dated 10th July, “pharmaceutical products” refer to pharmaceutical preparations consisting of one substance or a combination of substances that, when applying to human beings, can achieve the purposes of:

• Diagnosis, treatment, alleviation or prevention of diseases or the symptoms thereof;
• Diagnosis, treatment, alleviation of prevention of any abnormal physical and psychological conditions or the symptoms thereof;
• Alteration, modification, correct or restoration of any organic functions.

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4. What does “products with health benefits” mean?

This generally refers to the products that are suitable for a specific population, with the benefits of regulating the functional states of the human body systems, and not intended for treatment of diseases; commonly used health products are also an example of products with health benefits.

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5. What is an “advertisement”?

The term “advertisement” specified in the decree-laws involving pharmaceutical product advertising refers to any form of communication, information, marketing or incentive that directly or indirectly promotes the prescription, supply, sale, access or consumption of a pharmaceutical product.

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6. What are the basic requirements for advertising a pharmaceutical product in Macao?

To advertise a pharmaceutical product in Macao, the pharmaceutical product concerned must be legally licenced for sale in the territory, and the advertisement content must be authorised in advance by the Pharmaceutical Administration Bureau.

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7. How can I release an advertisement for products claiming health benefits in Macao?

Pursuant to paragraph 1 of article 16 of Law no. 7/89/M, it is mandatory to obtain prior authorisation from the Pharmaceutical Administration Bureau before releasing this kind of advertisement in Macao.

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8. Any differences in the target audience of various pharmaceutical product advertisements?

Pharmaceutical products requiring doctor’s prescription (prescription drugs) can only be advertised to health professionals, while non-prescription drugs can be publicized to the public. Hence, attention should be paid to discriminating the target audience when advertising pharmaceutical products.

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9. Can I publish a pharmaceutical product advertisement freely?

No. According to the stipulations of the relevant decree-laws, advertisement of pharmaceutical products can only be published with the prior authorisation of the Pharmaceutical Administration Bureau.

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10. I’d like to apply for prior authorisation to advertise a pharmaceutical product and a product claiming health benefits, which government department should I submit my application to?

The prior authorisation application can be submitted in writing to the Pharmaceutical Administration Bureau.

Address: Avenida Sidónio Pais, n.º 51, Edif. “China Plaza”, 1.º andar, Macau

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11. How can I apply for prior authorisation to advertise pharmaceutical products?

The applicant should submit a completed “Application Form for Advertisement of Pharmaceutical Products” with the proposed advertising script to the Pharmaceutical Administration Bureau. For audio/video advertisement, the audio/video materials (e.g. audio recordings, video clips, CD or VCD) of the production should be submitted. As for the advertising content, the applicant is required to submit literature and/or supporting documents verifying the truthfulness and legitimacy of the advertisement as stipulated in the relevant laws and decree-laws.

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12. What are the required documents for the application of prior authorisation for advertisement of products claiming health benefits?

The applicant should submit a completed “Application Form for Advertisement of Products Claiming Health Benefits” together with the proposed advertising script and a photocopy of the official letter of product classification issued by Pharmaceutical Administration Bureau. For audio/video advertisement, the audio/video materials (e.g. audio recordings, video clips, CD or VCD) of the production should be submitted. Besides, the applicant is required to submit literature and/or supporting documents verifying the truthfulness of the advertisement.

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13. How do I know if the advertising application has been approved? How much is the application fee?

It is stipulated that the decision of authorisation application shall be made in no more than 30 days upon receipt of the application form. If the application is rejected, the applicant will be notified in writing by the Pharmaceutical Administration Bureau; if the application is approved, an advertising licence will be issued for the pharmaceutical product, no fee or charge would be payable.

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14. What essential information should be contained in pharmaceutical product advertisements targeting the public?

Pharmaceutical product advertisements targeting the public must include a warning as stipulated in the relevant decree-law – “Users are advised to carefully read the information on the outer package, container or package insert; consult a doctor if in doubt or when symptoms persist.”

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15. What kind of information is prohibited in pharmaceutical product advertisements targeting the public?

According to the stipulations of Decree-Law no. 30/95/M dated 10th July, pharmaceutical product advertisements targeting the public shall not contain any element that:

• Gives an impression that medical consultation or surgical intervention is unnecessary, in particular by promising to provide diagnosis or treatment advice;
• Suggests the efficacy of the pharmaceutical product is guaranteed without side effects, or suggests superior or equivalent efficacy in comparison with another treatment of pharmaceutical product;
• Recommends that the use of the pharmaceutical product can enhance one’s health, or suggests that one’s health will be impaired if the pharmaceutical product is not used, except in the case of vaccination campaigns;
• Targets only or primarily at children;
• Encourage consumption of the pharmaceutical products by referring to the recommendations and reputation of scientists or health personnel;
• Suggests the pharmaceutical product as food, cosmetics or any other consumer products;
• Suggests that the safety and efficacy of the pharmaceutical product are based on the fact that it is a natural product;
• Invokes improper or misleading terminologies that the use of the pharmaceutical product is proved or guaranteed to cure a particular disease;
• Uses improper or misleading graphical representations to demonstrate the change in human body caused by diseases or injuries, or the action of the pharmaceutical product on the human body;
• Mentions the effect of the pharmaceutical product which has not been scientifically proven.

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16. What are the restrictions on the advertising content of products claiming health benefits?

According to the stipulations of Law no. 7/89/M, the advertising messages of the products claiming health benefits shall respect the truth, not distort the facts or mislead the advertisement recipients. Claims relating to the origin, nature, composition, properties and conditions of acquisition of the marketed goods or services must at all times be subject to proof. Meanwhile, it is prohibited to mislead or influence the advertisement recipients by artifices, subliminal form or deceptive means. It is also prohibited to mislead consumers with any direct or indirect use of falsification, omission, exaggeration or ambiguity.

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17. Is it permissible to mention the therapeutic indications in a pharmaceutical product advertisement targeting the public?

Yes, except for the mentioning of indications that may facilitate self-medication, in particular:

• Tuberculosis;
• Sexually-transmitted diseases;
• Other highly infectious diseases;
• Cancers and other neoplasm;
• Chronic insomnia;
• Diabetes and other metabolic diseases.

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18. Is it legal to distribute samples of medicines to the public?

The Decree-Law stipulates that no person shall provide free pharmaceutical products to the public for promotional purpose; therefore, it is illegal to distribute samples of medicines to the public.

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19. Which department is responsible for enforcing the penalties in the event of non-compliant advertisements?

According to article 31 of Law no. 7/89/M, the Pharmaceutical Administration Bureau is responsible for enforcing the fines for unauthorised advertisement of products claiming health benefits, while the Economic and Technological Development Bureau is responsible for enforcing the fines for non-compliant advertisements that are exaggerated or falsified.

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20. Are there any legal liabilities for the businesses involved in the non-compliant advertisement of pharmaceutical products?

The advertiser, advertising operator or publisher of the non-compliant advertisement shall assume joint and several liability on the payment of fines as stipulated in the legislation.

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21. How can I enquire about the advertisement of pharmaceutical products and products claiming health benefits?

For enquiries, you may contact the Advertising Unit of the Pharmaceutical Administration Bureau in person or by telephone at (853) 2883 1906 during office hours.

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