Annex 6

to the Procedure of confirmation of conformity

of pharmaceutical products manufacture
with the good manufacturing practice requirements
(sub-paragraph 8 paragraph 2 Clause II)

REFERENCE
on State control inspections results

at
________________
applicant:
________________
(name of the manufacturing site and applicant)

FROM _____ TO _____)

(specify the past three years to the date of application)

Inspection results
№ Name of regulatory Type of Period, date(s) Act (report) (give a reference
  authority inspection of inspections No. ___ on the document
(planned, from (date)  and provide a
unscheduled) brief summary
indicated in the
report/certificate)

1. State control agency of medicines of Ukraine

2 State body of the country where production is located (for non-residents)

3 Competent drug regulatory authorities-PIC/S members

4 The authorities of other countries

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Head of the Company: (Head-Quality) _____________ _____________________
(Position) (signature) (name)

Head of Quality Control: (Manager) ______________ __________________

(Qualified Person) (position) (signature) (name)

Stamp:

Date of preparation: ___________

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