By attending this course, you will learn

• Regulatory framework in Poland with key local legislations
• MAH requirements based on the Pharmaceutical Act, such as notification of initial placing into the market, shortage notification (temporary/permanent), „sunset clause”, annual fees
• Local regulatory requirements in line with various Regulations: MAA, variations, how to handle formal requirements in Poland, grouping „in consultations”, preparing mock ups and possibilites of MA withdrawal
• The Office for Registration of Medicinal Products for human use: structure, activities and quality policy

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