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Get Payment Form Fees For Type Ia Variations, Type Ia Variations Describing ...
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How to fill out the Payment Form Fees For Type Ia Variations online
This guide provides clear instructions on completing the Payment Form Fees For Type Ia Variations and its various components online. Following these steps will ensure that you accurately fill out the form, facilitating a smooth payment process.
Follow the steps to successfully complete the payment form online.
- Click ‘Get Form’ button to download the form and open it for editing.
- Begin by entering the medicinal product name in the designated field. This should reflect the exact name of the product for which the variation is requested.
- Fill in the pharmaceutical form, strength, and administration route. Specify the pharmaceutical form, followed by the strength of the product and the route of administration.
- Provide the marketing authorisation holder's information. Include their name, address, city, country, phone number, fax number, and email address.
- Indicate the type of authorisation procedure as 'National' if applicable.
- State the medicinal product’s status including the marketing authorisation (MA) number and date of issue. If the product is under an MA renewal procedure, please specify.
- Fill out the paying company's details similarly to how you filled out the marketing authorisation holder section. Include their name, address, city, country, phone number, fax number, email, fiscal code, trade register number, IBAN account, and bank.
- In the proposal for payment section, state the amount in Lei or Euro as required.
- Select the services for which you are paying by marking the relevant assessment application for type IA, IB, and II variations. If necessary, specify the variation numbers.
- Provide the contact details of the proposer, listing the representative office in Romania or the contact person’s name, address, city, country, phone number, fax number, and email.
- At the bottom of the form, ensure to sign and stamp where required, confirming the accuracy of the information you provided.
- Finally, save the completed form, and consider options to download, print, or share the document as needed.
Complete your payment form online today to ensure timely processing of your application.
Type IA variation: a change that will have only a minimal effect or no effect at all on the quality, safety or efficacy of the relevant medicinal product and is defined in the relevant Variation Guideline of the European Commission OR is defined via an article 5 recommendation of the CMDh.
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