Macao, China Special Administrative Region Imposes Pre-Approval for Pharmaceutical and Health-Claiming Products

Macao, China Special Administrative Region now requires prior approval for all advertisements of pharmaceutical products or products claiming health benefits, ensuring compliance with local advertising and drug supervision standards.

Regulation Analysis: Prior Approval for Pharmaceutical and Health-Related Product Advertisements in Macao

In Macao, China Special Administrative Region, all advertisements for pharmaceutical products or products claiming health benefits require prior approval from the Macao Pharmaceutical Administration Bureau (ISAF) before dissemination. This requirement is mandated under two key legal instruments: Decree-Law No. 7/89/M (September 4, 1989) and Decree-Law No. 30/95/M (July 10, 1995). Failure to obtain approval before publishing such advertisements is prohibited^{1, 2}.

1. Legal Basis and Scope

1.1 Applicable Regulations

1.2 Covered Products

• Pharmaceutical products: Any drug or medicinal product authorized for sale in Macao².
• Products claiming health benefits: Any product (e.g., food supplements, medical devices, or cosmetics) that makes explicit or implied claims about improving, maintaining, or restoring health¹.

1.3 Exemptions

• Prescription-only medicines (POM): Advertisements are restricted to healthcare professionals and may only appear in professional publications, samples, or information media targeting licensed practitioners².
• Non-health-related products: Advertisements for products without health claims (e.g., general consumer goods) are not subject to this requirement.

2. Approval Process

2.1 Eligibility

• Applicants: Individuals or legal entities (e.g., companies) intending to publish advertisements for covered products^{1, 2}.
• Product eligibility: Only products legally authorized for sale in Macao may apply for advertisement approval².

2.2 Required Documents

To apply for prior approval, the following must be submitted to ISAF:

1. Completed application form:
   • "Application for Pharmaceutical Advertisement" (for drugs)².
   • For multiple products, use the "Supplementary Page for Pharmaceutical Advertisement Application"².

1. Advertisement materials:
   • Text and visuals of the proposed advertisement.
   • For audiovisual advertisements (e.g., radio, TV, digital), submit the audio/video recording (e.g., CD, VCD, or digital file)².

1. Supporting documentation:
   • Evidence of product authorization: Proof that the product is legally registered and approved for sale in Macao².
   • Scientific/legal substantiation: Documents verifying the accuracy and legality of the health claims (e.g., clinical studies, regulatory approvals)².
   • Target audience verification (for prescription drugs):
   • If the advertisement targets healthcare professionals, provide proof that the publication or media outlet is exclusively for professionals (e.g., medical journals)².

2.3 Submission and Processing

• Submission location:

Macao Pharmaceutical Administration Bureau (ISAF) Address: 19th Floor, Government (Qingmao) Office Building, Avenida do Conselheiro Ferreira de Almeida, Macao^{1, 2}.

• Office hours:

Monday–Thursday: 9:00 AM–1:00 PM, 2:30 PM–5:45 PM Friday: 9:00 AM–1:00 PM, 2:30 PM–5:30 PM Closed on weekends and public holidays².

2.4 Fees

• Not specified in the provided sources^{1, 2}.

3. Key Compliance Obligations

1. Prohibition on Unapproved Advertisements:
   • No advertisement for pharmaceutical products or health-benefit products may be published, broadcast, or distributed in Macao without prior ISAF approval^{1, 2}.

1. Truthfulness and Legality:
   • Advertisements must not contain false, misleading, or unsubstantiated claims about health benefits or product efficacy^{1, 2}.
   • All claims must be supported by scientific or regulatory evidence².

1. Restrictions on Prescription Drugs:
   • Advertisements for prescription-only medicines are limited to healthcare professionals and may not target the general public².

1. Single-Use Application:
   • Each application form is valid for one advertisement only. Separate applications are required for multiple advertisements or products².

4. Enforcement and Penalties

While the provided sources do not specify penalties for non-compliance, the following enforcement mechanisms apply under Macao law:

• Advertisement removal: ISAF may order the immediate cessation of unapproved advertisements^{1, 2}.
• Legal action: Violations may result in fines, product seizures, or criminal liability under Macao’s broader pharmaceutical and advertising laws (e.g., Decree-Law No. 58/90/M on pharmaceutical products).

5. Contact Information

For inquiries or submissions, contact ISAF at:

• Address: 19th Floor, Government (Qingmao) Office Building, Avenida do Conselheiro Ferreira de Almeida, Macao.
• Phone: (+853) 2883 1906
• Fax: (+853) 2852 4016
• Email: info@isaf.gov.mo^{1, 2}.

Summary Answer

In Macao, prior approval from the Macao Pharmaceutical Administration Bureau (ISAF) is mandatory for all advertisements of pharmaceutical products (under Decree-Law No. 30/95/M) and products claiming health benefits (under Decree-Law No. 7/89/M)^{1, 2}. Applicants must submit a completed application form, advertisement materials, and supporting documents (e.g., product authorization, scientific evidence) to ISAF, which reviews submissions within 30 days². Advertisements for prescription drugs are restricted to healthcare professionals, and unapproved advertisements are prohibited^{1, 2}. Non-compliance may result in enforcement actions, including advertisement removal or legal penalties. For further details, contact ISAF via the provided channels^{1, 2}.

Sources

1. ↩ gov.mo — services / ps 1573 https://www.gov.mo/zh-hans/services/ps-1573/
2. ↩ gov.mo — ps 1573 / ps 1573a https://www.gov.mo/zh-hans/services/ps-1573/ps-1573a/