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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

207,000

Evaluation of generic products file for registration

90,000

Evaluation of generic products file for registration

(Intravenous solutions that do not contain active substances)

60,000

Registration Renewal of innovative and biological products

61,000

Registration Renewal of generic products

31,000

Registration Renewal of generic products

(Intravenous solutions that do not contain active substances)

26,000

Addition of new Pharmaceutical form

Innovative and biological

156,000

generic

80,000

generic Intravenous solutions

32,000

Addition of new strength

Innovative and biological

67,000

generic

40,000

generic Intravenous solutions

30,500

Addition of new pack size

Innovative and biological

54,000

generic

23,000

generic Intravenous solutions

19,000

Variation

3,500

Variation that needs lab analysis

7,000

Change of product name

7,500

Change of manufacturer name

11,000

Registration of manufacturer

46,000

Registration Renewal of manufacturer

45,000

Addition of new production line

15,000

Accreditation of Bioequivalence center

12,500

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