UAE Registration Requirements for

General Sale List (GSL) Products

In the United Arab Emirates (UAE), the General Sale List (GSL) includes Dietary Supplements, Medicated
Cosmetics, Antiseptic and Disinectants and Miscellaneous products !hich contains pharmaceutical in"redients
and#or a medical claim and cannot be classiied as medicines$
%he application can be made in En"lish or Arabic$ Mar&etin" authori'ation or GSL products in the United
Arab Emirates (UAE) can only be "i(en to companies (Manuacturer) !ho are re"istered in the UAE ministry
o health$ )elo! is a list o the GSL product re"istration re*uirements ollo!ed by the re*uirements or
re"isterin" a company in the UAE ministry o health$ Applicants in the UAE should ha(e Medical stores
licensed by the Ministry o +ealth$
,e"istration o the GSL -roduct re*uires.

/$ Application and document recei(in" orm or the ,e"istration o ne! GSL product (typed)$ A(ailable
rom the %echnical Aairs Section$
0$ Certiicate o -harmaceutical -roduct (C--) as per the 1+2 Certiication Scheme or 3ree Sale
Certiicate (3SC) or the product$
%o be issued by Competent Authorities in Country o 2ri"in, it must be authenticated by the orei"n
aairs section o the UAE or any GCC embassy in the country o ori"in$
%he C-- must contain.
%rade 4ame o the -roduct$
I the %rade 4ame o the product intended or re"istration in UAE is dierent rom that
in the Country o 2ri"in, dierence should be e5plained clearly in the C--#3SC and both
%rade 4ames should be mentioned !ith conirmation o similarity in composition and
other speciications$

Composition o the product in details (Acti(e and inacti(e in"redients !ith their
*uantities)$
4ame o the Manuacturer#Mar&etin" Authori'ation +older# Manuacturin" Site(s)#
Contract Manuacturer(s) !ith address$
Shel6lie o the product !ith Stora"e conditions$
Declaration that the product is reely sold in country o 2ri"in or less that 0 years$
7$ -ac&a"e Insert or the product authenticated rom Competent Authorities (i applicable)$
8$ %hree (7) samples o the product in its inal pac&a"e$
9$ Certiicate o Analysis o the same batch o the samples submitted or re"istration$
%he ollo!in" inormation must be submitted on company letterhead !ith lo"o, si"nature and stamp.

:$ Statement issued rom the -rincipal Company sho!in" that the product is de(oid rom hormones, hea(y
metals, antibiotics, steroids, deri(ati(es o por& and any natural and chemical in"redients ha(in"
harmul eects on human biolo"ical and beha(ioural unctions$ I the product contains an in"redient
rom animal source, the &ind o animal and part e5tracted rom it must be speciied percenta"e o
alcohol i any must be mentioned to"ether !ith reasons thereo$

Adopted rom M2+ Circular 4o$ 0; or 0;;/ issued by the Director o Dru" Control Department

<$ +alal certiicate issued by reco"ni'able or"ani'ations and authorities$

= Authenticated contract bet!een MA+ > a"ent mentionin" the products or !hich the a"ent is "oin"
to be responsible or$
? %he applicant should ha(e a medical store licensed by the Ministry o +ealth$ (as per the Circular 4o$ /
or year 0;;:)
/; (alid company re"istration certiicate issued by UAE # M2+ dru" control department
// Submit )SE # %SE ree certiicate rom competent authority in Country o ori"in (wherever applicable)
/0 outer label, inner label and insert o the product on stamped company letterhead$
/7 CD o art!or& (outer, inner label and insert) o the product in @-EG ormat$
I the product mar&etin" authori'ation holder (MA+) > manuacturer has not been re"istered in the UAE
ministry o health, then this must be done beore a product can be submitted or re"istration$
Documents required for GSL Company registration

Application is collected rom %echnical Aairs Section Secretary or do!nloaded rom the M2+ !ebsite,
the orms are PAR !"E (or MA+) > PAR #! (or manuacturin" site), at the end o each orm
there is a list o re*uired documents to be attached alon" !ith the orm, applications are to be illed and
stamped by the MA+ > manuacturer, documents are to be attached alon" !ith each orm$
4$)$. %he GSL re"istration committee may re*uest ACL analysis o the submitted products and the
applicant !ill ha(e to pro(ide necessary samples and other analysis re*uirements re*uested by the dru"
control laboratory$
4$).6 All orms and complete copy o "uidelines or company and product re"istration can be re*uested
rom the technical aairs section secretary, telephone ;06 ://<709 or do!nloaded rom the M2+ !ebsite at
the ollo!in" lin&.
http.##!!!$moh$"o($ae#mohBsite#pharBmed#mohBpBm$htm