Middle East Regulatory Policy Brief

Covering Monobenzone 20% Cream, Hizballah, SDN List, Da’esh, Reliance. Updates include SFDA recalls of Monobenzone 20% Cream and Selsen Shampoo, plus sanctions targeting Hizballah, Da’esh, and SDN List expansions. Key regulatory actions impacting pharmaceutical compliance and international security sanctions.

Show Notes

This episode covers essential regulatory developments affecting pharmaceutical products and international sanctions within the Middle East. Key topics include the SFDA's enforcement actions on Monobenzone 20% Cream and Selsen Shampoo, alongside updates on sanctions targeting Hizballah, Da’esh, and entities on the SDN List.

The Saudi Food and Drug Authority (SFDA) has mandated recalls of all batches of Monobenzone 20% Cream manufactured by SACO MEDICAL, citing non-compliance with pharmaceutical regulations. Healthcare providers are instructed to halt dispensing and quarantine stock for return. Similarly, Selsen Shampoo has been recalled due to regulatory non-compliance, with protocols in place for managing remaining supplies and patient advisories.

On the sanctions front, the U.S. Treasury has increased sanctions on Hizballah, targeting networks smuggling millions in cash. Additionally, updates include amendments to the UN Security Council's Da’esh and Al-Qaida sanctions list and designations related to counter-narcotics and terrorism financing. These developments highlight ongoing international efforts to combat illicit networks and enforce compliance.

For more information, visit the Carver Agents website.

Articles mentioned:
  1. 海外の医薬品簡略審査についてのページを更新しました。
  2. Treasury Increases Sanctions on Hizballah and Targets Network Smuggling Millions in Cash for Hizballah
  3. Treasury Increases Sanctions on Hizballah and Targets Network Smuggling Millions in Cash for Hizballah
  1. سحب جميع تشغيلات مستحضر Selsen Shampoo
  2. سحب جميع تشغيلات مستحضر Monobenzone 20% Cream
  1. Counter Narcotics, Counter Terrorism, Cuba-related, and Iran-related Designations; Issuance of Russia-related General License; Issuance of Associated Frequently Asked Questions
  2. Security Council ISIL (Da’esh) and Al-Qaida Sanctions Committee Amends 21 Entries on Its Sanctions List
  1. سحب جميع تشغيلات مستحضر Monobenzone 20% Cream
  2. سحب جميع تشغيلات مستحضر Selsen Shampoo

What is Middle East Regulatory Policy Brief?

Regulatory news, updates, and insights for countries in the Middle East presented by the Carver Agents team

Welcome to Carver's Middle East Regulatory Updates.

The Saudi Food and Drug Authority, or SFDA, has issued important recall decisions affecting pharmaceutical products in Saudi Arabia. All batches of Selsen Shampoo have been recalled due to non-compliance with pharmaceutical and herbal product regulations. Healthcare practitioners are required to immediately stop dispensing and using the affected batches. Remaining stock must be quarantined and returned to the supplier following the health facility’s return mechanism. Patients are advised to consult their healthcare providers before discontinuing use and to report any side effects through the SFDA’s electronic vigilance system.

Similarly, the SFDA has recalled all batches of Monobenzone 20% Cream, manufactured by SACO MEDICAL, for non-compliance with the Law of Pharmaceutical and Herbal Establishments and Products and its implementing regulations. Healthcare practitioners must cease dispensing and using these batches immediately. Remaining stock must be quarantined and returned to suppliers according to established return procedures. Patients should consult their healthcare providers before stopping use and report any adverse effects via the SFDA electronic vigilance system or by contacting the SFDA directly.

That wraps up today's regulatory updates. Visit carveragents.ai for more information.