emo France Medication Import Regulations

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6 years 7 months ago #2871

Hi,

My name is Laurent, I'm French.
Is there special regulations to Import medication to France ?

Regard,

Laurent

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6 years 7 months ago #2872

Hi Laurent, welcome to you, your best bet might be to send an email to This email address is being protected from spambots. You need JavaScript enabled to view it. he may have some answers for people in France and how they can import generics legally, or you could enquire with your customs service in France and ask what the laws are regarding importation of medicines for personal use, finding a willing doctor to write a script for the generic medicine may be a tougher proposition?, anyways, ask Greg Jeffrey's, he may have the answers.

Good luck to you.


GT 3, F3, Contracted 1993 Tx Naive
V/L 1,267,000 AST 67 ALT 65 6/10/15
commence Sof/Dac (Mesochem) 6/11/15
AST ALT normal 24/11 *
*V/L UNDETECTED 24/11*
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6 years 7 months ago #2926

In brief you can walk it in on your person, but not post it in. Here is an email from somebody in France who researched it. He picked up his medication in Australia a couple of weeks ago and is now back in Paris on treatment.

James,

I have found the text of the relevant French laws on importation/exportation of medicines. This confirms my previous indications that mailing medicines into France is not allow, but that importation by personal transport of a treatment for up to 3 months is allowed and does not require authorisation (Article R5121-110, below).

.

... So if you are thinking in terms of mailing from Bangladesh, and given what you know about the UK law already, it might seem that travelling to the UK for a pick-up could be a workable option for many European citizens (see again the link to French customs at end of this mail).

Best,

D


Source: www.legifrance.gouv.fr/affichCode.do?idS...LEGITEXT000006072665


Section 10 : Importation et exportation.
Article R5121-108 En savoir plus sur cet article... < www.legifrance.gouv.fr/affichCodeArticle...5&dateTexte=20151020 >
Modifié par Décret n°2013-66 du 18 janvier 2013 - art. 2 < www.legifrance.gouv.fr/affichTexteArticl...2&dateTexte=20130121 >

Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid >ou de l'autorisation temporaire d'utilisation mentionnée à l'article L. 5121-12 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid >ou de l'enregistrement mentionné à l'article L. 5121-13 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid > ou de l'autorisation mentionnée au 12° ou au 13° de l'article L. 5121-1 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid >ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche biomédicale qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid >fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid >, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid >et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche biomédicale, si la recherche biomédicale a fait l'objet d'un refus d'autorisation.

Article R5121-109 En savoir plus sur cet article... < www.legifrance.gouv.fr/affichCodeArticle...5&dateTexte=20151020 >
Modifié par Décret n°2012-597 du 27 avril 2012 - art. 5 < www.legifrance.gouv.fr/affichTexteArticl...6&dateTexte=20120430 >

Pour les produits finis, définis comme des médicaments ayant subi tous les stades de la fabrication, y compris le conditionnement, à l'exception des médicaments destinés à être stockés dans un entrepôt national d'exportation mentionné à l'article 277 A < www.legifrance.gouv.fr/affichCodeArticle...e=&categorieLien=cid > du code général des impôts, ainsi que des médicaments importés par un particulier par une autre voie que le transport personnel, une autorisation d'importation est requise pour chaque opération d'importation.

Pour les médicaments autres que les produits finis, pour les médicaments destinés à être stockés dans un entrepôt national d'exportation défini à l'article 277 A du code général des impôts, ainsi que pour les médicaments importés par un particulier par une autre voie que le transport personnel, l'autorisation d'importation est requise pour une série d'opérations d'importation envisagées pour un médicament pendant une période maximale d'un an et pour une quantité globale donnée ; dans ce cas, l'autorisation précise le nombre d'opérations prévues, la durée de la période pendant laquelle les opérations peuvent être effectuées ainsi que la quantité globale du médicament considéré pouvant être importée ; à l'issue de la période d'autorisation, le renouvellement ne peut être obtenu que sur présentation de l'autorisation précédente et de l'indication des opérations effectuées et de la quantité importée pendant la période. L'autorisation est retournée à l'Agence nationale de sécurité du médicament et des produits de santé dès que les opérations d'importation prennent fin et au plus tard à l'issue de la période couverte par cette autorisation, revêtue de la mention des quantités effectivement importées et des dates des opérations correspondantes.

L'autorisation d'importation peut être suspendue ou supprimée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé. Sauf en cas d'urgence, ces décisions ne peuvent intervenir qu'après que le titulaire de l'autorisation a été mis à même de présenter ses observations.

** Article R5121-110 En savoir plus sur cet article... < www.legifrance.gouv.fr/affichCodeArticle...5&dateTexte=20151020 >

* Les particuliers ne peuvent importer un médicament qu'en quantité compatible avec un usage thérapeutique personnel pendant une durée de traitement n'excédant pas trois mois aux conditions normales d'emploi ou pendant la durée de traitement prévue par l'ordonnance prescrivant le médicament. Lorsqu'ils transportent personnellement ce médicament, ils sont dispensés d'autorisation.

(truncated here)

.... more Articles on the French web site....


And here is the same advice from French customs (in French)

www.douane.gouv.fr/articles/a11946-le-tr...par-des-particuliers


Brief translation: an amount necessary for the treatment, or by default up to 3 months of treatment, is permitted when carried by the traveller himself; the prescription should be presented to customs, but it is not compulsory. For more than 3 months of treatment, the traveller must produce the original prescription. For narcotic or psychotropic drugs, a prescription is required, and special authorisation to transport bay also be required.


YMMV
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6 years 7 months ago #2940

Thank you James, Crazy8

I sent an email to Greg.
At the moment, I'm living at Réunion island until June 2016.
My idea is to call a Mauritanius Island gastro enterologist to check if they are able to order and receive medication from Indian or Bangladesh.
I think to Mauritius Island because it's near Réunion Island (about 30 min fly) and because this country is listed in the Gilead licensing agreement for developing countries. . May be it's a way to explore.
Will start to call Mauritius Island on Monday and will give you more detail about.

To finish, thank a lot, this forum give me a "new possible"

Laurent

Last Edit: 6 years 7 months ago by karilo. Reason: not complete

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6 years 7 months ago #3112

Hi,

Following my previous post, I have had a phone contact with a Mauritius gastro enterologist.
He could provide Generic Sofosbuvir (hepcvir from Cipla) for 1300 Euros the 12 weeks.
He propose : Sofosbuvir + Ribavirin + Interféron on 12 weeks
I would have to manage the Ribavirin + Interféron with a French gastro enterologist (next week)
However, after reading French forum and other documentation, I'm not really ok to go with interferon because it seems to be an out of date protocol.
The fact I can find generic Sofosbuvir from Mauritius at a decent price, with a good supply chain integrity, is a good new.
That said, Sofosbuvir seems to be not enough and the doctor don't speak at all about "Ledipasvir"

Regards,

Laurent

Last Edit: 6 years 6 months ago by karilo.

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6 years 7 months ago #3114

Hi karilo,

Yes interferon is pretty much avoided now, thanks to the new DDA's.

Depending on your genotype & whether you have cirrhosis or not, ribavirin is not necessarily needed either.

And yep that's my understanding too that you need a second DAA along with sof, and that could be ledipasvir, or daclatasvir.


GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 - 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 - 6 weeks UNDETECTED
AST 26
ALT 26
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6 years 7 months ago #3123

Hi Karilo

Well you can always try an purchase directly from Mesochem sof/led or sof dac? at approximately $1300US or $930US respectively. Than you can make the decision and have riba supply by a range of alternatives and perhaps from you local specialist? Just a thought? Em


Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.
Last Edit: 6 years 7 months ago by emilio.

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6 years 7 months ago #3127

Hello Emilio,

Is Mesochem actually offering $1300 or $930 USD pricing for Sof/Led or Sof/Dac?

If so can you please pass a copy of that offer on privately.


YMMV

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6 years 7 months ago #3141

Hi James

Im not sure of the latest.prices and obviously this would depend on the Australian dollar. The $930US sof/dac and $1350.US sof/led was about the ballpark when I ordered?

Can someone who has ordered APIs recently confirm the latest prices in US dollars.please. sorry if Ive under quoted here. I might havei missed changes. Em


Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.

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6 years 7 months ago #3142

Hi James

Im not sure of the latest.prices and obviously this would depend on the Australian dollar. The $930US sof/dac and $1350.US sof/led was about the ballpark when I ordered?

Can someone who has ordered APIs recently confirm the latest prices in US dollars.please. sorry if Ive under quoted here. I might havei missed changes. Em


Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.

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6 years 7 months ago #3143

Sorry Karilo

We were purchasing sof/led for $1900US. sorry I had this as AU dollar and reduced it down in previous post. Forgive my brain atm. So approximates. sof/dac 930 US or 1900US and these could be old. Em


Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.

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6 years 7 months ago #3144

Could someone put a more recent price list up and in the mean time I will talk with rachel to get some updated list from China. Ballpark $1000-$2000. Em


Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.
Last Edit: 6 years 7 months ago by emilio.

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6 years 2 months ago #14420

Good news,

Just to let you know I have started an Harvoni treatment :cheer:

Laurent

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6 years 2 months ago #14421

That's great news Karilo. :)

Are you able to share how you did it so others in France may benefit?


G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:

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6 years 1 month ago #16014

Hi,

I followed the "anormal" french circuit which say you must me at least F3 (or F2 severe) to be cured.
The cost for 12 weeks treatment is 45 000 Euros for social security system :angry:
Anyway, it's done for me, thank you god.
However, I'm speaking with other french gui and we would like to know where the buyer club is legaly able to send hep c treatment. I know it's possible with UK, but is it possible with Italy for exeample ?

Regards,

Laurent

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