HU: Submission requirements updated by NIP

The Hungarian National Institute of Pharmacy (NIP) has updated their national submission requirements for medicinal products for human use. According to the new requirements, the provision of 4 copies of the application form is no longer required. In case of electronic submissions (eCTD or NeeS), the following documents must be provided in addition:

Documents with original signatures

• Application form (declaration and signature)
• Cover letter
• Declaration of identity
• Data exclusivity declaration
• Patent declaration (only for applications with legal basis Art 8(3) and Art 10b)
• Annex 5.4 Power of attorney

Further deliverables:

• Module 1.3 product information texts in MS Word
• Proof of Payment
• Sample of the active substance and finished product

[Source: NIP website]

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