The Pharma Legal Handbook: Asia Growth & Transition Market
The Pharma Legal Handbook: Baltics
Articles
Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, Saudi Arabia has implemented two types of Managed Entry Agreements (MEAs) under the Ministry of Health’s “Managed-Entry Agreement Policy” issued in January 2021. These include: A. Finance-based Price/Volume Agreement 1. Fundamentals & rationale The Marketing Authorization Holder (MAH)…
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health. STEPS A. Drugs and Biological and medicinal products Before the application for…
Panama AFRA June 2019
Regulatory Reforms: Panama
1. Are there proposals for reform or significant change to the healthcare system? Pre-project Law No. 12 which revokes law 462 of March 18, 2025, which modifies, adds to, revokes articles of law 51 of December 27, 2005, which reforms the organic law of the social security fund and enacts other provisions. 2. When…
What are the pricing models, processes and principles for originator drugs? Drugs are provided by a medical institution or pharmacy to a patient based on the NHI Drug Price (a patient pays 10%, 20% or 30% (depending on age and other conditions) of the NHI Drug Price). As detailed in Question I. 2. a. above,…
A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?…
Saudi Arabia Youssry Saleh Law Firm June 2019
Post Market-Approval Processes and Regulations: Saudi Arabia
What are the pricing models, processes and principles for originator drugs? Originator drugs (innovator medicines) are priced by the Saudi Food and Drug Authority (SFDA) following the principles outlined in its 2023 Drug Pricing Guidelines. The pricing process includes: External Reference Pricing (ERP): SFDA compares prices with a reference basket of 34 countries. Internal Reference…
Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoids are substances subject to national control for therapeutic, medical, veterinary, scientific and research use. 2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The regulatory authorities are the Pharmaceutical and Drug Department from the Ministry of Health and the Ministry of…
In addition to the clinical data obtained through clinical studies please list the data required for a. Market approval In addition to clinical trial data, the following documents are required for market authorization in Saudi Arabia: Quality/CMC Module: Includes full GMP certificates (PIC/S or WHO type) and a local QP release plan. Non-clinical studies:…
Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The Ministry of Health (MOH) is the primary body responsible for public health in Saudi Arabia. It sets national health policies, issues licenses to healthcare providers (public and private), oversees public hospitals and primary…
Panama AFRA June 2019
Patents and Trademarks: Panama
1. What are the basic requirements to obtain patent and trademark protection? The basic requirements for obtaining a patent are the following: Power of attorney granted by the applicant; no legalization nor notarization required Assignment Document legalized by Panamanian Consulate or Apostille Specifications, claims, abstract and drawings (if applicable). If the applicant is a natural…
