The requirements for opting for the abbreviated procedure for new Sanitary Registrations are established
Executive Decree No. 112 of 2022 establishes the requirements to opt for the abbreviated procedure for new Sanitary Registrations. It is established that only the following Regulatory Authorities of the following High Standard countries are recognized:
| Country/Region | Strict Authority |
| WORLD HEALTH ORGANIZATION (WHO) | |
| Australia | Therapeutic Product Administration (TGA) |
| Austria | Austrian Agency for Health and Food Safety (AGES) |
| Belgium | Federal Agency for Drugs and Health Products (AFMPS) |
| Canada | Health Canada |
| Cyprus | Ministry of Health |
| Denmark | Danish Medicines Agency (DKMA) |
| Finland | Finnish Medicines Agency (FIMEA) |
| French | Commerce and Industry Chamber of Paris II de France |
| Germany | Federal Ministry of Health (BMG) Central Authority of the Länder for the Protection of Health concerning Medicinal Products and Medical Devices (ZLG) |
| Iceland | Icelandic Medicines Agency (AIFA) |
| Ireland | Health Products Regulatory Authority ( |
| Italy | Italian Medicines Agency (AIFA) |
| Japan | Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) |
| Liechtenstein | Liechtenstein Health Office/Department of Medicines |
| Holland | Ministry of Health, Welfare and Sport |
| Portugal | INFARMED National Medicines and Products Authority of Health i.p. |
| Spain | Spanish Agency for Medicines and Health Products (AEMPS) |
| Sweden | Medical Products Agency (MPA) |
| Switzerland | Swiss Agency for Therapeutic Products (Swissmedic) |
| United Kingdom | Regulatory Agency for Medicines and Healthcare products (MHRA) |
| United States | Food and Drug Administration (FDA) |
| Europe | European Medicines Agency (EMA) |
| New Zealand | Drug and Medical Device Safety Authority (MEDSAFE) |
| Norway | Norwegian Medicines Agency (NOMA) |
| PAN AMERICAN HEALTH ORGANIZATION (PAHO) | |
| Argentina | National Administration of Drugs, Food and Medical Technology (ANMAT) |
| Brazil | National Agency for Medicines, Food and Medical Technology (ANVISA) |
| Chile | Institute of Public Health (ISP) |
| Colombia | National Institute for Drug and Food Surveillance (INVIMA) |
| Cuba | Center for the State Control of the Quality of Medicines (CECMED) |
| Mexico | Federal Commission for the Protection against Sanitary Risks (COFEPRIS) |
Likewise, the Decree establishes that the abbreviated procedure will only be recognized to registrations of new products, renewals and post-registration changes for medicines that have been registered and openly marketed in these countries.
If you would like to know more about the requirements to carry out an abbreviated sanitary registration in the Republic of Panama, please do not hesitate to contact us at quijano@quijano.com.
