In this case, such requests might be submitted at the same meeting.Ĥ. An exception to this limit is granted to requests to register different concentrations of the same dosage form (each in a separate application). Import and toll companies could submit only two applications per month at two different meetings. The maximum number of applications that could be submitted by one company (local manufacturer) is four applications per month at four different meetings.
CAPA will send back an email informing the applicant with the date and time for application submission within 3 working days.ģ. The Applicant sends an appointment request by e-mail to the Central Administration of Pharmaceutical Affairs (CAPA)Ģ. The registration process starts by receiving the Registration Submission Request via e-mail as described in the following guidelines:ġ. We would like to note that although the process of registering a drug with the Ministry of Health is a long procedure that may take up to 4 years to finalize, as we will further explain, it is irrelevant of the patent protection granted to the drug in question. This restriction applies to drugs either prepared domestically or imported from abroad.Īny medicine should be registered with The Egyptian Drug Authority (EDA) – the pharmaceutical regulatory body of the Egyptian Ministry of Health (MOH) – and given a MOH Registration Number before it can be traded or given to people. Article 59 of Law 1 states that pharmacies may not sell drugs that are not registered with the Ministry of Health.
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