Additional Information May be Included in Labeling and Packaging

Regulatory authorities are cracking down on labeling and packaging requirements for medicines and medical devices to ensure transparency and accuracy. As of recent developments, manufacturers must adhere to strict guidelines outlined in the RTCA (Regulatory Technical Committee for Medicines and Medical Devices) 11.01.02:04 annex of Resolution No. 143-2005 (COMIECO-XXXII).

Restrictions on Labeling and Packaging

Labeling and packaging must comply with these regulations, which include:

• Adherence to RTCA standards
• Clear and concise labeling
• Accurate and precise product information
• Compliance with specific guidelines for each type of medicine or medical device

Marketing and Advertising Restrictions

Marketing and advertising of medicines and medical devices are also subject to strict regulations. Key requirements include:

• Compliance with RTCA standards
• Truthful and accurate claims
• Disclosure of all relevant information
• Compliance with specific guidelines for each type of product

Consequences of Non-Compliance

Failure to comply with these regulations can result in severe penalties, including:

• Administrative sanctions
• Criminal and civil liability
• Suspension or revocation of licenses

Call to Action

In light of these developments, manufacturers are urged to review their labeling and packaging practices to ensure compliance with RTCA standards. Failure to do so may result in serious consequences.

Sources:

• RTCA 11.01.02:04 annex of Resolution No. 143-2005 (COMIECO-XXXII)
• Law on Drugs and Pharmacies, Law No. 292
• Regulation of Law No.292, Law on Drugs and Pharmacies