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Fees

العربية تحت رعاية صاحب المعالي وزير الصحة المهندس خالد بن عبد العزيز

Fees


                                                                                          

Type of Submission

Total fees for central registration and GCC

SAR

Evaluation of innovative and biological products for registration

204,000

Evaluation of generic products file for registration

87,000

Evaluation of generic products file for registration

(Intravenous solutions that do not contain active substances)

57,000

Renewal Registration of innovative and biological products

60,000

Renewal Registration of generic products

30,000

Renewal Registration of generic products

(Intravenous solutions that do not contain active substances)

25,000

Addition of new Pharmaceutical form

Innovative and biological

153,000

generic

77,000

generic – Intravenous solutions

29,000

Addition of new strength

Innovative and biological

64,000

generic

37,000

generic – Intravenous solutions

27,500

Addition of new pack size

Innovative and biological

51,000

generic

20,000

generic – Intravenous solutions

16,000

Variation

3,250

Variation that needs lab analysis

6,750

Change of product name

7,500

Change of manufacturer name

11,000

Registration of manufacturer

46,000

Renewal Registration of manufacturer

45,000

Addition of new production line

15,000

Accreditation of Bioequivalence center

10,500

Pre-registration pricing consultation

45,000

Replacement of lost certificate

1,000





Good Manufacturing Practice Evaluation Fees :

Region Visit Fees
1

Arabic Countries (First Group)

Gulf States, Yemen, Iraq, Jordan, Syria, Lebanon, Egypt

61,000 SR
2

Arabic Countries (Second Group)

Libya, Algeria, Tunisia, Morocco

95,000 SR
3​Africa100,000 SR
4Europe – Turkey121,000 SR
5

South East Asia

Malaysia, Singapore, India, Pakistan, Iran, Thailand, Philippines

95,000 SR
6South & North America161,000 SR
7China, Korea, Republics of Central Asia115,000 SR
8Japan, Russia147,000 SR
9Australia, New Zealand184,000 SR