National Scope Variations

Concerning the below mentioned variations the applicants are kindly requested to submit the Application Form downloaded from here.

1. TRANSFER OF THE MARKETING AUTHORISATION TO A NEW HOLDER („MAH TRANSFER”)
2. CHANGE IN THE LEGAL STATUS OF THE PRODUCT
3. COMBINATION OF THE REGISTRATION NUMBERS
4. INCLUDE/EXCLUDE PACK SIZES IN THE HUNGARIAN MARKETING AUTHORISATION WITHIN THE VALUES APPROVED IN MRP/DCP

Information about MAH-transfer procedures:

Changing of the marketing authorization holder may cause the change of the Pharmacovigilance System.

Therefore the Applicant shall make a statement in EVERY CASE whether the Pharmacovigilance System has changed.

In addition the following documents need to be submitted:

1. In case the Pharmacovigilance System remaine unchanged (responsible company is the same), two other declarations need to be submitted.

1. The new MAH owns the appropriate Pharmacovigilance System and a qualified Person; has to be originally signed by the future MAH and the EU QPPV.

2. Authorisation of the future MAH to the company responsible for Pharmacovigilance System; has to be originally signed by both sides.

In case the Pharmacovigilance System remains Unchanged 3 declarations need to be submitted.

2. In case of the change of the Pharmacovigilance System, a new, Type C.I.8. variation application has to be submitted. In this case GYEMSZI-OGYI suspends the variation for MAH-transfer until the variation for changing the Pharmacovigilance System is ended positively.

In case of changing the Pharmacivigilance System 1 statement and 1 variation application need to be submitted.