natgillin/translations-raw huggingface dataset:
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets. 
Vse navedbe zgoraj navedenih indikacij je treba izbrisati iz ustreznih poglavij navodil za uporabo.
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets 
Spremembe ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
The medicine has an acceptable safety profile. 
Zdravilo ima sprejemljiv varnostni profil.
In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks. 
V obeh študijah so dajali 6,5 mg zdravila Intrarosa enkrat dnevno 12 tednov.
What measures are being taken to ensure the safe and effective use of Intrarosa? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Intrarosa?
The full EPAR for Intrarosa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Intrarosa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is not intended to provide practical advice on how to use Intrarosa. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Intrarosa must not be used in patients with the following conditions: genital bleeding where the cause has not been diagnosed, known or suspected breast cancer or oestrogen-dependent cancer, previous breast cancer, untreated endometrial hyperplasia (thickening of the lining of the womb), acute (shortterm) liver disease, previous liver disease where liver function tests are still abnormal, previous or current venous thromboembolism (formation of blood clots in the veins), thrombophilic disorders (abnormal blood clotting), active or recent arterial thromboembolic disease (disease caused by blood clots in the arteries), porphyria (inability to break down chemicals called porphyrins). 
Zdravilo Intrarosa se ne sme uporabljati pri bolnicah z naslednjimi stanji: nepojasnjena genitalna krvavitev, znan rak dojk ali rak, ki je občutljiv na estrogene, ali sum nanju, pretekli rak dojk, nezdravljena hiperplazija endometrija (zadebeljena maternična sluznica), akutna (kratkotrajna) bolezen jeter, pretekla bolezen jeter (če so testi delovanja jeter še vedno nenormalni), pretekla ali sedanja venska tromboza (tvorjenje krvnih strdkov v venah), trombofilne bolezni (nenormalno strjevanje krvi), aktivna ali nedavna arterijska trombembolična bolezen (bolezen, ki jo povzročijo krvni strdki v arterijah), porfirija (nezmožnost razgradnje kemikalij, imenovanih porfirini).
Other information about Intrarosa 
Druge informacije o zdravilu Intrarosa
Pain during sexual intercourse was self-assessed by patients using a standard scale ranging from 0 (no pain) to 3 (severe pain). 
Bolečino med spolnim odnosom so bolnice ocenile same s standardno lestvico v razponu od 0 (brez bolečine) do 3 (močna bolečina).
The European Medicines Agency therefore considered that Intrarosa's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Intrarosa večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Intrarosa. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Intrarosa.
The company that markets Intrarosa is required to conduct a study on how the medicine is used in clinical practice, including whether it is used according to the authorised product information. 
Družba, ki trži zdravilo Intrarosa, mora izvesti študijo o tem, kako se zdravilo uporablja v klinični praksi in ali se uporablja v skladu z odobrenimi informacijami o zdravilu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intrarosa have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Intrarosa upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What benefits of Intrarosa have been shown in studies? 
Kakšne koristi je zdravilo Intrarosa izkazalo v študijah?
Why is Intrarosa approved? 
Zakaj je bilo zdravilo Intrarosa odobreno?
What are the risks associated with Intrarosa? 
Kakšna tveganja so povezana z zdravilom Intrarosa?
For more information about treatment with Intrarosa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Intrarosa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Intrarosa is available as a 6.5 mg pessary. 
Zdravilo Intrarosa je na voljo v obliki 6,5-miligramske vaginalne globule.
Women should insert the pessary into their vagina, once daily, at bedtime. 
Ženske naj vaginalno globulo vstavijo v vagino enkrat dnevno pred spanjem.
The most common side effect with Intrarosa (which may affect up to 1 in 10 people) is vaginal discharge. 
Najpogostejši neželeni učinek zdravila Intrarosa (ki se lahko pojavi pri največ 1 bolnici od 10) je vaginalni izcedek.
Two studies involving 813 post-menopausal women with vulvar and vaginal atrophy found that treatment with Intrarosa was more effective than placebo (a dummy treatment) at reducing signs of thinning (atrophy) of vaginal tissues. 
V dveh glavnih študijah z 813 ženskami po menopavzi z atrofijo vulve in vagine so ugotovili, da je zdravljenje z zdravilom Intrarosa učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri zmanjšanju znakov tanjšanja (atrofije) tkiva vagine.
Intrarosa contains the active substance prasterone, also known as dehydroepiandrosterone (DHEA). 
Zdravilo Intrarosa vsebuje zdravilno učinkovino prasteron, znano tudi kot dehidroepiandrosteron (DHEA).
What is Intrarosa and what is it used for? 
Kaj je zdravilo Intrarosa in za kaj se uporablja?
Patients taking Intrarosa had a modest reduction in pain during sexual intercourse, which was similar or better to the effect seen in patients taking placebo. 
Bolnice, ki so uporabljale zdravilo Intrarosa, so imele zmerno zmanjšanje bolečine med spolnim odnosom, kar je bilo podobno ali boljše kot pri učinkih, ki so jih opazili pri bolnicah, ki so prejemale placebo.
The effect seen in the placebo group was explained by the lubricant effect of the excipient. 
Učinek, ki so ga opazili v skupini, ki je prejemala placebo, so razložili z mazivnim učinkom pomožne snovi.
In women with vulvar and vaginal atrophy, the wall of the vagina and surrounding tissues become thinner and can cause symptoms such as dryness, irritation and soreness around the genital area, and painful sexual intercourse. 
Pri ženskah z atrofijo vulve in vagine se stena vagine in obdajajoča tkiva stanjšajo, kar povzroča simptome, kot so suhost, razdraženost in vnetje okoli genitalnega predela ter boleč spolni odnos.
The pain reduced by 1.3 and 1.4 points with Intrarosa compared with 0.9 and 1.1 points with placebo. 
Bolečina se je pri uporabi zdravila Intrarosa zmanjšala za 1,3 v eni in 1,4 točke v drugi študiji, pri jemanju placeba pa za 0,9 v eni in 1,1 točke v drugi študiji.
As a result of increasing oestrogen levels, the number of superficial cells in the tissues in and around the vagina increases thus relieving the symptoms of vaginal atrophy. 
Kot rezultat povečanih ravni estrogena se zviša število površinskih celic v tkivu v vagini in okrog nje, kar olajša simptome atrofije vagine.
Intrarosa is a medicine used to treat postmenopausal women with moderate to severe symptoms of vulvar and vaginal atrophy. 
Zdravilo Intrarosa se uporablja pri ženskah po menopavzi z zmernimi do hudimi simptomi atrofije vulve in vagine.
For practical information about using Intrarosa, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Intrarosa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Intrarosa has been shown to improve the structure of the vaginal tissues and to have a modest effect on pain during sexual intercourse. 
Dokazali so, da zdravilo Intrarosa izboljša zgradbo tkiva v vagini in ima zmeren učinek na bolečino med spolnim odnosom.
In addition, Intrarosa treatment was better at increasing acidity in the vagina (which normally becomes less acidic with atrophy), with pH values reducing by 0.9 and 1.0 with Intrarosa and by 0.2 and 0.3 with placebo. 
Poleg tega je bilo zdravljenje z zdravilom Intrarosa boljše pri povečanju kislosti vagine (ki pri atrofiji običajno postane manj kisla), pri čemer se je pri uporabi zdravila Intrarosa pH-vrednost zmanjšala za 0,9 v eni in 1,0 v drugi študiji, pri uporabi placeba pa za 0,2 v eni in 0,3 v drugi študiji.
Results showed that the number of superficial cells (which normally falls with atrophy) increased by 6% and 10% with Intrarosa compared with about 1% and 2% with placebo. 
Rezultati so pokazali, da se je število površinskih celic (ki pri atrofiji običajno upade) pri uporabi zdravila Intrarosa povečalo za 6 % v eni in 10 % v drugi študiji, pri uporabi placeba pa za približno 1 % v eni in 2 % v drugi študiji.
The active substance of Intrarosa, prasterone, is converted into the sex hormones oestrogens and androgens when inserted into the vagina. 
Zdravilna učinkovina v zdravilu Intrarosa, prasteron, se po vstavitvi v vagino pretvori v spolna hormona estrogen in androgen.
How is Intrarosa used? 
Kako se zdravilo Intrarosa uporablja?
For the full list of side effects reported with Intrarosa, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Intrarosa, glejte navodilo za uporabo.
In women who have been through the menopause, the thinning of the tissues in and around the vagina is caused by a fall in levels of the sex hormone oestrogen. 
Pri ženskah po menopavzi pride do tanjšanja tkiva v vagini in okrog nje zaradi padca ravni spolnega hormona estrogena.
There was also a decrease in the number of parabasal cells (which normally increase with atrophy) of 42% and 47% with Intrarosa compared with 2% and 12% with placebo. 
Rezultati so pokazali tudi, da se je število parabazalnih celic (ki se pri atrofiji običajno poveča) pri uporabi zdravila Intrarosa zmanjšalo za 42 % v eni in 47 % v drugi študiji, pri uporabi placeba pa za 2 % v eni in 12 % v drugi študiji.
How does Intrarosa work? 
Kako zdravilo Intrarosa deluje?
Strength Pharmaceutical Form Route of Administration 
1 ml (50 mg/ml) 12 napolnjenih injekcijskih peresnikov + 12 alkoholnih blazinic
Content (concentration) 
1 ml (50 mg/ml) 4 napolnjeni injekcijski peresniki + 4 alkoholne blazinice
Contaminated clothing should be removed immediately. 
Kontaminirana oblačila je treba nemudoma odstraniti.
People must not eat, drink or smoke while using the medicine. 
Uporabniki ne smejo jesti, piti ali kaditi, ko uporabljajo zdravilo.
Dead mites were counted daily in the first study and three times per week in the second study for three weeks post treatment. 
V prvi študiji so mrtve varoje preštevali vsakodnevno, v drugi študiji pa trikrat na teden tri tedne po zdravljenju.
In case of eye contact, the affected eye should be rinsed thoroughly with water (contact lenses should be removed first). 
V primeru stika z očmi je treba prizadeto oko nemudoma temeljito izprati z vodo (najprej je treba odstraniti kontaktne leče).
The full EPAR for Oxybee can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila Oxybee je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The effectiveness of Oxybee to kill mites was 97% and 95% in these studies. 
V teh študijah je bila učinkovitost zdravila Oxybee pri ubijanju varoj 97 % oziroma 95 %.
This is a summary of the European public assessment report (EPAR) for Oxybee. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Oxybee.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Oxybee's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Oxybee večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The effectiveness of Oxybee against varroa mites was investigated in two field studies in European countries with different climates. 
Učinkovitost zdravila Oxybee proti varoji so proučevali v dveh terenskih študijah v evropskih državah z različnimi podnebji.
The dispersion should be warmed to 30-35˚C before application. 
Disperzijo je treba pred nanosom ogreti na 30-35 °C.
Used measuring devices and empty containers should be disposed of immediately in a safe way. 
Uporabljene merilne pripomočke in prazne vsebnike je treba takoj in varno odstraniti.
Hands and exposed skin should be washed with soap and plenty of water immediately. 
Roke in izpostavljene dele kože je treba takoj umiti z milom in obilo vode.
If the product is accidentally swallowed by a person, their mouth should be cleaned with water and water or milk should be drunk, but vomiting should not be induced. 
Če človek zdravilo nenamerno zaužije, si mora usta izprati z vodo ter piti vodo ali mleko, vendar bruhanja ne sme izzvati.
In the first study treatment with Oxybee was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Oxybee was compared to a group with no treatment. 
V prvi študiji so zdravljenje z zdravilom Oxybee primerjali z drugim zdravilom, ki vsebuje oksalno kislino, in z nezdravljeno skupino, v drugi študiji pa so zdravilo Oxybee primerjali z nezdravljeno skupino.
Oxybee is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose). 
Zdravilo Oxybee je zelo kislo in je lahko dražilno ali jedko za kožo, oči in sluznice (notranjo površino telesnih votlin, kot so usta in nos).
Oxybee is trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3˚C. 
Zdravilo Oxybee se nakaplja na čebele v panju in se sme uporabljati le, kadar je temperatura zunaj panjev vsaj 3 °C.
Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor). 
Varoza je bolezen medonosnih čebel, ki jo povzroča infestacija s parazitom, imenovanim varoja (Varroa destructor).
How oxalic acid works on mites is not well understood but is thought to be due to the acidity of the medicine, which kills the mites on contact. 
Učinek oksalne kisline na varoje ni dobro razumljen, vendar se predvideva, da je posledica kislosti zdravila, ki ob stiku uniči varoje.
It is not intended to provide practical advice on how to use Oxybee. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Other information about Oxybee 
Druge informacije o zdravilu Oxybee
Protective clothing, acid resistant gloves and safety glasses should be worn during treatment. 
Med dajanjem zdravila je treba nositi zaščitno obleko, rokavice, odporne proti kislini, in varnostna očala.
What are the risks associated with Oxybee? 
Kakšna tveganja so povezana z zdravilom Oxybee?
The most common side effect with Oxybee (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths. 
Najpogostejši neželeni učinek zdravila Oxybee (ki lahko prizadene več kot 1 od 10 čebeljih kolonij) je povečano število smrti čebel, kar pa ni dolgoročno vplivalo na razvoj kolonij.
Contact with these areas should be avoided, both directly and by hand-to-mouth or hand-to-eye contact. 
Stiku s temi predeli se je treba izogibati, in sicer neposrednemu stiku ter stiku med roko in usti ali med roko in očmi.
Oxybee is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription. 
Zdravilo Oxybee je na voljo kot prašek in raztopina za pripravo disperzije za čebeljo družino (tekočine za uporabo znotraj panja) in se izdaja brez recepta.
What benefits of Oxybee have been shown in studies? 
Kakšne koristi je zdravilo Oxybee izkazalo v študijah?
What is Oxybee and what is it used for? 
Kaj je zdravilo Oxybee in za kaj se uporablja?
Why is Oxybee approved? 
Zakaj je bilo zdravilo Oxybee odobreno?
Oxybee is a medicine used to treat varroosis in honey bee colonies. 
Oxybee je zdravilo, ki se uporablja za zdravljenje varoze v kolonijah medonosnih čebel.
The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption. 
Karenca je čas, ki mora preteči po uporabi zdravila, preden se med lahko uporabi za prehrano ljudi.
The withdrawal period for honey from honey bees treated with Oxybee is ‘zero' days, which means there is no mandatory waiting time. 
Karenca za med medonosnih čebel, zdravljenih z zdravilom Oxybee, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Medical advice should be sought immediately and the package leaflet or label shown to the doctor. 
Nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Oxybee oxalic acid 
Oxybee oksalna kislina
For practical information about using Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Oxybee naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Oxybee naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Oxybee can only be used on colonies without brood. 
Zdravilo Oxybee se sme uporabljati samo pri kolonijah brez zalege.
The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees; the mite can also help spread viruses and bacteria. 
Varoja se hrani s hemolimfo (krvjo) odraslih čebel in z zalego (razvojnimi stopnjami medonosnih čebel), kar povzroči poškodbe in/ali smrt čebel.
Oxybee contains the active substance oxalic acid. 
Zdravilo Oxybee vsebuje zdravilno učinkovino oksalno kislino.
The European Commission granted a marketing authorisation valid throughout the EU for Oxybee on 1 February 2018. 
Evropska komisija je dovoljenje za promet z zdravilom Oxybee, veljavno po vsej Evropski uniji, izdala
How does Oxybee work? 
Kako zdravilo Oxybee deluje?
How is Oxybee used? 
Kako se zdravilo Oxybee uporablja?
Date of first authorisation: 28 April 2014 Date of last renewal: 
Datum prve odobritve: 28. april 2014 Datum zadnjega podaljšanja:
It is important to initiate treatment as early as possible. 
Pomembno je, da se zdravljenje začne čim prej.
It is not known whether elderly patients respond differently from younger patients. 
Ni znano, ali se ti bolniki odzivajo drugače kot mlajši bolniki.
These studies however, are of limited relevance. 
Pomen teh študij je omejen.
No differences in the safety profile were observed. 
V varnostnem profilu niso opazili nobenih razlik.
Submission of final study report: 
Oddaja končnega poročila o študiji:
Elderly patients (≥ 65 years old) 
Posebne skupine bolnikov Starejši bolniki (≥ 65 let starosti)
Safety and pharmacodynamic results in these patients are consistent with results observed in the first 52 weeks (see section 4.8). 
Rezultati varnosti in farmakodinamični rezultati pri teh bolnikih so v skladu z rezultati, ki so jih opazili v prvih 52 tednih (glejte poglavje 4.8).
As a result, these substances do not get broken down and processed by the body as they should. 
Zaradi tega telo teh snovi ne razgrajuje in ne presnavlja, kot bi jih moralo.
Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI). 
Dojenčki in majhni otroci (mlajši od 2 let) morda še nimajo diagnoze dedne intolerance na fruktozo (HFI).
• the risk of anaphylaxis and of severe allergic reactions and the measures necessary to minimise it: 
• tveganje anafilakse in resnih alergijskih reakcij ter ukrepe, ki so potrebni za njihovo zmanjšanje:
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data). 
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
These problems can be a part of the disease and may be caused by pressure on your spinal cord. 
Te težave so lahko povezane z boleznijo in jih lahko povzroči pritisk na hrbtenjačo.
The posology in the paediatric population is the same as in adults. 
Odmerjanje pri pediatrični populaciji je enako kot pri odraslih bolnikih.
See leaflet for further information. 
Glejte navodila za nadaljnje informacije.
- If you have an allergic reaction during your infusion your doctor may slow down, or stop your infusion. 
- Če imate alergijsko reakcijo med infuzijo, lahko vaš zdravnik upočasni ali prekine infuzijo.
Vimizim should not be mixed with other medicinal products in the same infusion, except for those mentioned below. 
Zdravilo Vimizim se ne sme mešati z drugimi zdravili v isti infuziji, razen s tistimi, ki so navedena spodaj.
Patients with HFI cannot break down fructose, which may cause serious side effects. 
Bolniki s HFI ne morejo razgrajevati fruktoze, kar lahko povzroči resne neželene učinke.
For intravenous infusion only. 
Samo za intravensko infuzijo.
Patients continued a long-term follow-up observational study for at least another 52 weeks, for a total of 104 weeks. 
Bolniki so nato vsaj nadaljnjih 52 tednov sodelovali v dolgoročni opazovalni študiji, skupno 104 tedne.
Set up a MPS IVA disease Registry to assess the long term safety and efficacy of elosulfase alfa. 
Vzpostaviti register bolezni MPS IVA za ocenjevanje dolgoročne varnosti in učinkovitosti elosulfaze alfa.
The current medical standards for emergency treatment are to be followed. 
Upoštevati je treba veljavne standarde za nudenje nujne medicinske pomoči.
Mean half-life (t1/2) increased from 7.52 minutes at Week 0 to 35.9 minutes at Week 22. 
Povprečni razpolovni čas (t1/2) se je s 7,52 minute v tednu 0 povečal na 35,9 minute v 22. tednu.
Because this is a protein solution, slight flocculation (thin translucent fibres) may occur. 
Ker je to raztopina beljakovin, se lahko pojavi rahla flokulacija (tanka prosojna vlakna).
This medicine may improve the symptoms of MPS IVA. 
To zdravilo lahko ublaži simptome bolezni MPS IVA.
Each infusion will take approximately 4 hours. 
Vsaka infuzija bo potekala približno 4 ure.
Your doctor or nurse will give you some medicines before your treatment to reduce allergic reactions and you may also be given medicines to help control any fever. 
Zdravnik ali medicinska sestra vam bosta pred zdravljenjem dala zdravila za zmanjšanje alergijskih reakcij, morda pa boste prejeli tudi zdravila, ki bodo pomagala nadzirati morebitno vročino.
Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority. 
Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet dogovoriti z nacionalnim pristojnim organom o vsebini in obliki izobraževalnega programa.