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 Disin ectants and Miscellaneous products !hich contains pharmaceutical in"redients and#or a medical claim and cannot be classi ied 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 (Manu acturer) !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 A airs Section$ 0$ Certi icate o -harmaceutical -roduct (C--) as per the 1+2 Certi ication Scheme or 3ree Sale Certi icate (3SC) or the product$ %o be issued by Competent Authorities in Country o 2ri"in, it must be authenticated by the orei"n a airs 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 di erent rom that in the Country o 2ri"in, di erence should be e5plained clearly in the C--#3SC and both %rade 4ames should be mentioned !ith con irmation o similarity in composition and other speci ications$ Composition o the product in details (Acti(e and inacti(e in"redients !ith their *uantities)$ 4ame o the Manu acturer#Mar&etin" Authori'ation +older# Manu acturin" Site(s)# Contract Manu acturer(s) !ith address$ Shel 6li e 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$ Certi icate o Analysis o the same batch o the samples submitted or re"istration$ %he ollo!in" in ormation 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" harm ul e ects 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 speci ied 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 certi icate 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 to be responsible or$ "oin"

? %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 certi icate issued by UAE # M2+ dru" control department // Submit )SE # %SE ree certi icate 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+) > manu acturer has not been re"istered in the UAE ministry o health, then this must be done be ore a product can be submitted or re"istration$ Documents required for GSL Company registration Application is collected rom %echnical A airs Section Secretary or do!nloaded rom the M2+ !ebsite, the orms are PAR !"E ( or MA+) > PAR #! ( or manu acturin" 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+ > manu acturer, 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$).6 All orms and complete copy o "uidelines or company and product re"istration can be re*uested rom the technical a airs section secretary, telephone ;06 ://<709 or do!nloaded rom the M2+ !ebsite at the ollo!in" lin&. http.##!!!$moh$"o($ae#mohBsite#pharBmed#mohBpBm$htm