Medicines agency bans export of well-known diabetes drug
The State Agency of Medicines has prohibited pharmaceuticals wholesalers from selling diabetes drug Ozempic 1 mg outside Estonia as the manufacturer is experiencing serious supply difficulties in Europe.
The agency prohibited exports of the Ozempic 1 mg solution for injection in pre-filled pen (four doses N1, sales permit no. EU/1/17/1251) from Estonia until the end of the year.
"The export ban has been forwarded to all pharmaceuticals wholesalers in Estonia and will be observed. The State Agency of Medicines receives information on drug exports through the permits system and quarterly reports," Marko Tiisler, head of the agency's imports and exports monitoring department, said.
Tiisler added that manufacturer Novo Nordisk notified the agency of Ozempic supply difficulties in the European Union caused by increased demand and manufacturing hurdles. While it remains unclear how long disruptions could last, the sales permit holder forecasts supply to remain strained into next year.
"Ozempic is marketed in three different doses in Estonia – 0.25, 0.5 and 1 milligrams. The manufacturer said that while there are no disruptions in supply in Estonia at this time, they will likely develop. We looked at past exports, analyzed inventory and supply forecasts and, based on the sales permit holder's info, decided to ban exports of the Ozempic 1 mg solution for injection in pre-filled pen."
The ban does not apply to retail sales and people taking the drug with them when they travel abroad.
Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
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Editor: Marcus Turovski